Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TERN-701 · 2 trials · 1 indication
Urine will be collected to determine the Aeurine,14C,t1-t2 of radiolabeled \[14C\]-TERN-701.
Urine will be collected to determine the Aeurine,14C of radiolabeled \[14C\]-TERN-701.
Feces will be collected to determine the Aefeces,14C,t1-t2 of radiolabeled \[14C\]-TERN-701.
Feces will be collected to determine the Aefeces,14C of radiolabeled \[14C\]-TERN-701.
Urine and Feces will be collected to determine the Aetotal,14C,t1-t2 of radiolabeled \[14C\]-TERN-701.
Urine and Feces will be collected to determine the Aetotal,14C of radiolabeled \[14C\]-TERN-701. Calculated as, Aetotal,14C= Aeurine,14C +Aefeces,14C.
Blood samples will be collected to determine the Cmax of TERN-701.
Blood samples will be collected to determine the Tmax of TERN-701.
Blood samples will be collected to determine the t1/2 of TERN-701.
Blood samples will be collected to determine the AUC0-Last of TERN-701.
Blood samples will be collected to determine the AUC0-inf of TERN-701.
Blood samples will be collected to determine the CL/F of TERN-701.
Blood samples will be collected to determine the Vz/F of TERN-701.
Blood samples will be collected to determine the Total \[14C\]-Radiolabel, calculated as the AUCinf of non-radiolabeled TERN-701 in plasma divided by the AUCinf of total \[14C\]-radiolabel in plasma.
Blood samples will be collected to determine the Tmax of radiolabeled \[14C\]-TERN-701.
Blood samples will be collected to determine the t1/2 of radiolabeled \[14C\]-TERN-701.
Blood samples will be collected to determine the AUC0-last of radiolabeled \[14C\]-TERN-701.
Blood samples will be collected to determine the AUC0-Inf of radiolabeled \[14C\]-TERN-701.
Blood samples will be collected to determine the Cmax of radiolabeled \[14C\]-TERN-701.
Blood samples will be collected to determine the Tmax of radiolabeled \[14C\]-TERN-701.
Blood samples will be collected to determine the t1/2 of radiolabeled \[14C\]-TERN-701.
Blood samples will be collected to determine the AUC0-last of radiolabeled \[14C\]-TERN-701.
Blood samples will be collected to determine the AUC0-Inf of radiolabeled \[14C\]-TERN-701.
Blood samples will be collected to determine the Cmax of radiolabeled \[14C\]-TERN-701.
Urine samples will be collected to determine the Aeurine of radiolabeled \[14C\]-TERN-701.
Urine samples will be collected to determine the CLr of radiolabeled \[14C\]-TERN-701.
Urine samples will be collected to determine the %Feurine of radiolabeled \[14C\]-TERN-701.
Feces samples will be collected to determine the Aefeces of radiolabeled \[14C\]-TERN-701.
Feces samples will be collected to determine the %Fefeces of radiolabeled \[14C\]-TERN-701.
Blood samples will be collected to determine the Percentage of AUC of \[14C\]-radiolabel TERN-701 metabolite in plasma.
Feces samples will be collected to determine the percentage of administered dose of \[14C\]-radiolabel TERN-701 metabolite in feces.
Urine samples will be collected to determine the percentage of \[14C\]-radiolabel TERN-701 metabolite in urine.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience a treatment emergent AE will be reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Blood pressure will be measured after the participant has been at rest in a supine position for at least 10 minutes. Blood pressure and pulse measurements will be assessed with a completely automated device; manual techniques will be used only if an automated device is not available. Blood pressure measurements will be carried out before blood sample collections or at least 30 minutes after any blood draws.
Blood pressure will be measured after the participant has been at rest in a supine position for at least 10 minutes. Blood pressure and pulse measurements will be assessed with a completely automated device; manual techniques will be used only if an automated device is not available. Blood pressure measurements will be carried out before blood sample collections or at least 30 minutes after any blood draws.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with abnormal hematology-related AEs will be reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with abnormal chemistry-related AEs will be reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with abnormal urinalysis-related AEs will be reported.
During the 12-lead ECG collection participants will be instructed to lie supine for at least 10 minutes prior to ECG collection. During the collection, participants should be in a quiet setting, without distractions, and should refrain from talking or moving their arms or legs. All ECG acquisitions will be carried out before any blood sample collections or at least 30 minutes after any blood draws.
Blood samples will be collected to determine the AUC0-Last of TERN-701.
Blood samples will be collected to determine the AUC0-inf of TERN-701.
Blood samples will be collected to determine the AUCtau of TERN-701.
Blood samples will be collected to determine the Cmax of TERN-701.
Blood samples will be collected to determine the t1/2 of TERN-701.
Blood samples will be collected to determine the Tmax of TERN-701.
| Arm | Type | Description |
|---|---|---|
| [14C]-TERN-701 | EXPERIMENTAL | Participants receive a single oral dose of radiolabeled TERN-701 (\[14C\]-TERN-701) on Day 1. |
| Cohort 1: Single Ascending Dose (SAD) Escalation of TERN-701 Dose Level 1 | EXPERIMENTAL | Participants receive a single oral dose of TERN-701 Dose Level 1 under fasted conditions on Day 1. |
| Cohort 2: SAD Escalation of TERN-701 Dose Level 2 | EXPERIMENTAL | Participants receive a single oral dose of TERN-701 Dose Level 2 under fasted conditions on Day 1. |
| Cohort 3: SAD Escalation of TERN-701 Dose Level 3 and Food Effect | EXPERIMENTAL | On Period 1 Day 1, participants receive a single oral dose of TERN-701 Dose Level 3 under fasted conditions. On Period 2 Day 1, participants receive TERN-701 Dose Level 3 after a high-fat meal. |
| Cohort 4: SAD Escalation of TERN-701 Dose Level 4 | EXPERIMENTAL | Participants receive a single oral dose of TERN-701 Dose Level 4 under fasted conditions on Day 1. |
| Cohort 5: SAD Escalation of TERN-701 Dose Level 5 | EXPERIMENTAL | Participants receive a single oral dose of TERN-701 Dose Level 5 under fasted conditions on Day 1. |
| Cohort 6: SAD Escalation of TERN-701 Dose Level 7 | EXPERIMENTAL | Participants receive a single oral dose of TERN-701 Dose Level 7 under fasted conditions on Day 1. |
| Cohort 7: TERN-701 Formulations with Rabeprazole 20 mg | EXPERIMENTAL | Participants in Cohort 7 are randomized to receive TERN-701 Formulation 1 or Formulation 2 at Dose Level 5 on Day 1. On Day 7, participants receive TERN-701 Formulation 2 or Formulation 1 at Dose Level 5. Participants also receive Rabeprazole 20 mg once daily on Days 10-13. On Day 14, participants will co-administer a single oral dose of Rabeprazole 20 mg with TERN-701 Formulation 1 Dose Level 5 at the same time. All participants receive treatment under fasted conditions. |
| Cohort 8: TERN-701 + Probe Substrate Cocktail-1 | EXPERIMENTAL | Per protocol, the probe substrate cocktail-1 consists of midazolam 2 mg, digoxin 0.25 mg, pravastatin 40 mg, montelukast 10 mg, and omeprazole 40 mg. On Day 1, participants receive a single oral dose of the probe substrate cocktail-1 under fasted conditions. On Day 5, participants receive a single oral dose of TERN-701 Dose Level 4 co-administered with a single oral dose of the probe substrate cocktail-1 taken at the same time under fasted conditions. On Day 9, participants receive a single oral dose of TERN-701 Dose Level 7 co-administered with a single oral dose of the probe substrate cocktail-1 taken at the same time under fasted conditions. |
| Cohort 9: TERN-701 Dose Level 5 + Rabeprazole 20 mg | EXPERIMENTAL | Participants receive a single oral dose of TERN-701 Dose Level 5 on Day 1 under fasted conditions. On Days 4-7 participants will receive Rabeprazole 20 mg once daily under fasted conditions. On Day 8, under fasted conditions, participants co-administer a single oral dose of TERN-701 Dose Level 5 with a single oral dose of Rabeprazole 20 mg taken at the same time under fasted conditions. |
| Cohort 10: SAD Escalation of TERN-701 Dose Level 8 | EXPERIMENTAL | Participants receive a single oral dose of TERN-701 Dose Level 8 under fasted conditions on Day 1. |
| Cohort 11: SAD Escalation of TERN-701 Dose Level 9 | EXPERIMENTAL | Participants receive a single oral dose of TERN-701 Dose Level 9 under fasted conditions on Day 1. |
| Cohort 12: TERN-701 Dose Level 3 + Itraconazole 200 mg | EXPERIMENTAL | Participants receive a single oral dose of TERN-701 at Dose Level 3 under nonfasted conditions on Day 1. On Day 8, participants will receive Itraconazole 200 mg twice daily after a standardized breakfast and evening snack. On Days 9-11, participants will take a single oral dose of Itraconazole 200 mg after a standardized meal. On Day 12, participants will take a single dose of Itraconazole 200mg after a standardized meal followed by TERN-701 Dose Level 3 taken an hour later. Participants will continue taking a single oral dose of Itraconazole 200 mg once daily after a standardized meal on Days 13-15. |
| Cohort 13: Multiple Ascending Dose (MAD) Escalation of TERN-701 Dose Level 4 | EXPERIMENTAL | Participants receive an oral dose of TERN-701 Dose Level 4 once daily from Day 1 to Day 13 under fasted conditions. |
| Cohort 14: TERN-701 Dose Level 5 + Probe Substrate Cocktail-2 | EXPERIMENTAL | Per protocol, the probe substrate cocktail-2 consists of midazolam 2 mg, warfarin 5 mg, and rosuvastatin 10 mg. Participants receive a single oral dose of the Probe Substrate Cocktail-2 on Day 1 under fasted conditions. On Days 9-15, participants receive a single oral dose of TERN-701 Dose Level 5 once daily under fasted conditions. On Day 16, participants receive a single oral dose of the Probe Substrate Cocktail-2 co-administered with TERN-701 Dose Level 5 taken at the same time under fasted conditions. On Days 17-21 participants receive TERN-701 Dose Level 5 as a single oral dose once daily under fasted conditions. |
| Cohort 15: TERN-701 Dose Level 8 + Probe Substrate Cocktail-2 | EXPERIMENTAL | Per protocol, the probe substrate cocktail-2 consists of midazolam 2 mg, warfarin 5 mg, and rosuvastatin 10 mg. Participants receive a single oral dose of the Probe Substrate Cocktail-2 on Day 1 under fasted conditions. On Days 9-15, participants receive a single oral dose of TERN-701 Dose Level 8 once daily under fasted conditions. On Day 16, participants receive a single oral dose of the Probe Substrate Cocktail-2 co-administered with TERN-701 Dose Level 8 taken at the same time under fasted conditions. On Days 17-21 participants receive TERN-701 Dose Level 8 as a single oral dose once daily under fasted conditions. |
| Cohort 16: Food Effect on TERN-701 Dose Level 8 Formulations with Rabeprazole 20 mg | EXPERIMENTAL | On Period 1 Day 1, participants receive a single oral dose of TERN-701 Formulation 3 Dose Level 8. On Period 1 Day 7, participants receive a single oral dose of TERN-701 Formulation 4 Dose Level 8. On Period 1 Day 13, participants receive a single oral dose of TERN-701 Formulation 5 Dose Level 8. On Period 1 Day 19, participants receive a single oral dose of TERN-701 Formulation 6 Dose Level 8. All Period 1 treatments are administered under fasted conditions. Per protocol, following Period 1, one formulation is selected for Period 2. On Period 2 Day 1, participants receive a single oral dose of the selected TERN-701 formulation Dose Level 8 after a high-fat meal. On Period 2 Days 7-10, participants receive rabeprazole 20 mg once daily under fasted conditions. On Period 2 Day 11, participants receive the selected formulation of TERN-701 Dose Level 8 as a single oral dose, co-administered with the single oral dose of Rabeprazole 20 mg taken at the same time under fasted conditions. |
| Cohort 17: Food Effect on TERN-701 Dose Level 8 Selected Formulation with Rabeprazole 20 mg | EXPERIMENTAL | Per protocol, a formulation from Cohort 16 Period 1, different from the formulation selected for Cohort 16 Period 2, may be selected to evaluate the effects of food and rabeprazole 20 mg. On Day 1, participants receive a single oral dose of the selected formulation of TERN-701 Dose Level 8 under fasted conditions. On Day 7, participants receive a single oral dose of the selected formulation of TERN-701 Dose Level 8 after a high-fat meal. On Days 13-16, participants receive a single oral dose of rabeprazole 20 mg once daily. On Day 17, participants receive a single oral dose of the selected formulation of TERN-701 Dose Level 8 co-administered with a single oral dose of rabeprazole 20 mg taken at the same time under fasted conditions. |
| Cohort 18: TERN-701 Dose Level 8 + Bosentan 125 mg | EXPERIMENTAL | On Day 1, participants receive a single oral dose of TERN-701 Dose Level 8 under fasted conditions. Beginning on Day 8, participants receive an oral dose of Bosentan 125 mg twice daily. On Day 15, participants receive TERN-701 Dose Level 8 as a single oral dose co-administered with the morning dose of Bosentan 125 mg taken at the same time under fasted conditions; participants then receive the second daily dose of Bosentan 125 mg in the evening. Participants continue taking Bosentan 125 mg twice daily on Days 16-18. |
| Cohort 19: TERN-701 Dose Level 6 + Quinidine 300 mg | EXPERIMENTAL | Participants receive a single oral dose of TERN-701 Dose Level 6 on Day 1 under fasted conditions. Beginning on Day 6, participants receive an oral dose of Quinidine 300 mg three times daily. On Day 8, participants receive TERN-701 Dose Level 6 as a single oral dose co-administered with the morning final dose of Quinidine 300 mg taken at the same time under fasted conditions. |
| Name | Type | Description |
|---|---|---|
| TERN-701 | DRUG | Oral Liquid radiolabeled with \[14C\]-TERN-701 |
| Rabeprazole | DRUG | The United States commercially marketed 20 mg oral tablet formulation is being used in this trial. |
| Midazolam | DRUG | 2 mg oral syrup formulation administered as part of the probe substrate cocktail-1 and probe substrate cocktail-2. The United States commercially marketed formulation is being used in this trial. |
| Digoxin | DRUG | 0.25 mg oral tablet formulation administered as part of the probe substrate cocktail-1. The United States commercially marketed formulation is being used in this trial. |
| Pravastatin | DRUG | 40 mg oral tablet formulation administered as part of the probe substrate cocktail-1. The United States commercially marketed formulation is being used in this trial. |
| Montelukast | DRUG | 10 mg oral tablet formulation administered as part of the probe substrate cocktail-1. The United States commercially marketed formulation is being used in this trial. |
| Omeprazole | DRUG | 40 mg oral tablet formulation administered as part of the probe substrate cocktail-1. The United States commercially marketed formulation is being used in this trial. |
| Itraconazole | DRUG | The United States commercially marketed 200 mg oral capsule formulation is being used in this trial. |
| Warfarin | DRUG | 5 mg oral tablet formulation administered as part of the probe substrate cocktail-2. The United States commercially marketed formulation is being used in this trial. |
| Rosuvastatin | DRUG | 10 mg oral tablet formulation administered as part of the probe substrate cocktail-2. The United States commercially marketed formulation is being used in this trial. |
| Bosentan | DRUG | The Europe commercially marketed 125 mg oral tablet formulation is being used in this trial. |
| Quinidine | DRUG | The United States commercially marketed 300 mg oral tablet formulation is being used in this trial. |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has body mass index (BMI) ≥18.5 and ≤32.0 kg/m\^2 * Is in good health Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has history or presence of any me...