Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ETX0282 · 1 trial · 1 indication
min, minutes
| Arm | Type | Description |
|---|---|---|
| Part A (SAD): Cohort 1, 100 mg ETX0282/Placebo | EXPERIMENTAL | Part A of the study will explore the safety, tolerability, and pharmacokinetics (PK) of a single ascending dose (SAD) of oral ETX0282. Participants will be treated with a single oral dose of 100 milligrams (mg) ETX0282 or placebo in a fasted state. They will be confined to the Study Unit from Day -1 and discharged following collection of the 72-hour postdose assessments (Day 4). |
| Part A (SAD): Cohort 2, 200 mg ETX0282/Placebo | EXPERIMENTAL | Part A of the study will explore the safety, tolerability, and PK of a SAD of oral ETX0282. Participants will be treated with a single oral dose of 200 mg ETX0282 or placebo in a fasted state. They will be confined to the Study Unit from Day -1 and discharged following collection of the 72-hour postdose assessments (Day 4). |
| Part A (SAD): Cohort 3, 400 mg ETX0282/Placebo | EXPERIMENTAL | Part A of the study will explore the safety, tolerability, and PK of a SAD of oral ETX0282. Participants will be treated with a single oral dose of 400 mg ETX0282 or placebo in a fasted state. They will be confined to the Study Unit from Day -1 and discharged following collection of the 72-hour postdose assessments (Day 4). |
| Part A (SAD): Cohort 4, 800 mg ETX0282/Placebo | EXPERIMENTAL | Part A of the study will explore the safety, tolerability, and PK of a SAD of oral ETX0282. Participants will be treated with a single oral dose of 800 mg ETX0282 or placebo in a fasted state. They will be confined to the Study Unit from Day -1 and discharged following collection of the 72-hour postdose assessments (Day 4). |
| Part A (SAD): Cohort 5, 600 mg ETX0282/Placebo | EXPERIMENTAL | Part A of the study will explore the safety, tolerability, and PK of a SAD of oral ETX0282. Participants will be treated with a single oral dose of 600 mg ETX0282 or placebo in a fasted state. They will be confined to the Study Unit from Day -1 and discharged following collection of the 72-hour postdose assessments (Day 4). |
| Part A (SAD): Cohort 6 (Elderly), 300 mg ETX0282/Placebo | EXPERIMENTAL | Part A of the study will explore the safety, tolerability, and PK of a SAD of oral ETX0282. Elderly participants (aged 65 years or older) will be treated with a single oral dose of 300 mg ETX0282 or placebo in a fasted state. They will be confined to the Study Unit from Day -1 and discharged following collection of the 72-hour postdose assessments (Day 4). |
| Part B (Food Effect): Cohort 7, 100 mg ETX0282/Placebo | EXPERIMENTAL | Part B of the study will explore the effect of food on oral ETX0282. Participants will be treated with a single oral dose of 100 mg ETX0282 or placebo (Day 1) while fasted and with a single oral dose of 100 mg ETX0282 or placebo (Day 4) with a high-fat meal. They will be confined to the Study Unit from Day -1 and discharged following collection of the 72-hour post fed state dose assessments (Day 7). |
| Part C (MAD): Cohort 9, 200 mg ETX0282/Placebo | EXPERIMENTAL | Part C of the study will explore the safety, tolerability, and PK of MAD of oral ETX0282. Part C will be administered in a fed state. Participants will be treated with a single oral dose of 200 mg ETX0282 or placebo on the morning of Day 1, and will then be dosed three times a day (TID) beginning on the morning of Day 2 (i.e., 24 hours after the Day 1 dose) through Day 7. Participants will be treated with a single oral dose of 200 mg ETX0282 or placebo on the morning of Day 8. They will be confined to the Study Unit from Day -1 and discharged following collection of the 72-hour post Day 8 dose assessments (Day 11). |
| Part C (MAD): Cohort 10, 200 mg ETX0282/Placebo | EXPERIMENTAL | Part C of the study will explore the safety, tolerability, and PK of MAD of oral ETX0282. Part C will be administered in a fed state. Participants will be treated with a single oral dose of 200 mg ETX0282 or placebo on the morning of Day 1, and will then be dosed TID beginning on the morning of Day 2 (i.e., 24 hours after the Day 1 dose) through Day 7. Participants will be treated with a single oral dose of 200 mg ETX0282 or placebo on the morning of Day 8. They will be confined to the Study Unit from Day -1 and discharged following collection of the 72-hour post Day 8 dose assessments (Day 11). |
| Part D: Cohort 12, ETX0282/Placebo plus Cefpodoxime Proxetil | EXPERIMENTAL | Part D of the study will explore the safety, tolerability, and PK of oral ETX0282 when administered as a single oral dose in combination with cefpodoxime proxetil tablets to healthy participants in a fed state. Participants will be treated with a single oral dose of 600 mg ETX0282 or placebo in a fed state on Day 1, with a single oral dose of 400 mg cefpodoxime proxetil in a fed state on Day 4, and with a single oral dose of 600 mg ETX0282 or placebo plus a single oral dose of 400 mg cefpodoxime proxetil dosed at the same time in a fed state on Day 7. They will be confined to the Study Unit from Day -1 and discharged following collection of the 72-hour post Day 7 dose assessments (Day 10). |
| Part B (Food Effect): Cohort 14, 300 mg ETX0282/Placebo | EXPERIMENTAL | Part B of the study will explore the effect of food on oral ETX0282. Participants will be treated with a single oral dose of 300 mg ETX0282 or placebo (Day 1) while fasted and with a single oral dose of 300 mg ETX0282 or placebo (Day 4) with a high-fat meal. They will be confined to the Study Unit from Day -1 and discharged following collection of the 72-hour post fed state dose assessments (Day 7). |
| Part G: Cohort 17, 300 mg ETX0282/Placebo | EXPERIMENTAL | Part G of the study will explore the tolerability and PK profile of oral ETX0282 when administered either as a single dose (i.e., 300 mg as a single dose) or in 4 equal, divided doses over a 6 hour period (i.e., 75 mg every 2 hours for 4 doses \[a 300 mg total dose\]) when administered in a fasted state. Participants will receive the 2 treatments in a cross-over design according to one of 2 randomized sequences: AB or BA. Treatment A: 0 hours, 4 × 75 mg ETX0282/placebo; 2, 4, and 6 hours, 1 × 75 mg placebo. Treatment B: 0 hours, 1 × 75 mg ETX0282/placebo and 3 × 75 mg placebo; 2, 4, and 6 hours, 1 × 75 mg ETX0282/placebo. Participants will be confined to the Study Unit from Day -1 and discharged following collection of the 24 hours post Day 4 dose assessments (Day 5). |
| Name | Type | Description |
|---|---|---|
| ETX0282 | DRUG | Oral Gelatin capsules |
| Cefpodoxime proxetil | DRUG | Oral tablets |
| Placebo | DRUG | Oral Gelatin capsules |
Inclusion Criteria: * Aged 18 to 55 years (inclusive) for all participants except for those in Cohort 6 (in Part A); for Cohort 6, only participants aged ≥ 65 years will be enrolled. * Be in general good health without clinically significant medical history * Provide voluntary written informed cons...
ETX0282 is an investigational small molecule being developed by Innoviva, Inc. (INVA). It is currently in Phase 1 clinical development. The drug is being studied for use in healthy volunteers, and it is administered orally.
ETX0282 is being studied for use in healthy volunteers. It is an investigational small molecule in Phase 1 clinical development. The drug is administered orally, and its safety, tolerability, and pharmacokinetics are being evaluated in clinical trials.
ETX0282 is being developed by Innoviva, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol INVA. The drug is currently in Phase 1 clinical development.
ETX0282 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to evaluate its safety, tolerability, and pharmacokinetics.
ETX0282 has one completed Phase 1 clinical trial, registered as NCT03491748. This study evaluated the safety, tolerability, and pharmacokinetics of ETX0282 when administered orally to healthy participants. The trial enrolled 99 participants in Australia and was completed.