Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-831 T2 · 2 trials · 2 indications
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug.
Clinical Laboratory parameters included tests for chemistry, hematology and urinalysis. Markedly abnormal values during treatment period were categorized as: alanine aminotransferase (ALT)\>3.0 U/L\*upper limit of normal(ULN), albumin\<25 g/L, alkaline phosphatase \>3.0 U/L\*ULN, aspartate aminotransferase \>3.0 U/L\*ULN, bilirubin \>3.42 umol/L creatinine \>177umol/L, gamma glutamyl transferase (GGT) \>3 U/L\*ULN, glucose \<2.8 mmol/L, \>19.4 mmol/L, potassium\<3 mmol/L, \>6 mmol/L, sodium \<130 mmol/L, \>150 mmol/L, protein \<0.8 g/L,\* lower limit of normal (LLN), \>1.2 g/L\*ULN, erythrocytes \<0.8 (10\^12/L)\*LLN, \>1.2 (10\^12/L)\*ULN, hematocrit (%) \<0.8\*LLN, \>1.2\*ULN, hemoglobin \<0.8 g/L\*LLN, \>1.2 g/L\*ULN, leukocytes \<0.5 (10\^9/L)\*LLN, \>1.5 (10\^9/L)\*ULN, platelets \<75(10\^9/L), \>600(10\^9/L). Only categories with values have been reported.
Vital signs included temperature, pulse rate and blood pressure. Markedly abnormal values during treatment period were categorized as: Pulse Rate (beats/min) \<50-\>120, Systolic Blood Pressure (SBP) (mmHg) \<85-\>180, Diastolic Blood Pressure (DBP) (mmHg) \<50-\>110 and Temperature (degree centigrades) \<35.6- \>37.7.
A 12-lead ECG was performed. Markedly abnormal values during treatment period were categorized as: ECG Mean Heart Rate (beats/min) \<50-\>120, PR Interval, Aggregate (msec) \<=80-\>=200, QRS Duration, Aggregate (msec) \<=80-\>=180, QT Interval, Aggregate (msec) \<=300-\>=460, QTcF Interval, Aggregate (msec) \<=300-\>=500 OR \>=30 change from baseline and \>=450 milliseconds.
| Arm | Type | Description |
|---|---|---|
| Fasted (T2 50 mg+T3 50 mg+T3 600 mg+T2 600 mg)+Fed (T3 600 mg) | EXPERIMENTAL | TAK-831 T2 50 milligram (mg), tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There will be a washout period of at least 7 days between study drug in-take in subsequent treatment periods. |
| Fasted (T3 50 mg+T2 600 mg+T2 50 mg+T3 600 mg)+Fed (T3 600 mg) | EXPERIMENTAL | TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There will be a washout period of at least 7 days between study drug in-take in subsequent treatment periods. |
| Fasted (T2 600 mg+T3 600 mg+T3 50 mg+T2 50 mg)+Fed (T3 600 mg) | EXPERIMENTAL | TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There will be a washout period of at least 7 days between study drug in-take in subsequent treatment periods. |
| Fasted (T3 600 mg+T2 50 mg+T2 600 mg+T3 50 mg)+Fed (T3 600 mg) | EXPERIMENTAL | TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There will be a washout period of at least 7 days between study drug in-take in subsequent treatment periods. |
| Placebo (Pooled) | OTHER | TAK-831 placebo-matching suspension, orally, once daily (QD) for up to Day 16. |
| TAK-831 100 mg | EXPERIMENTAL | TAK-831 100 mg, tablets, orally, QD on Days 1 and 3 to 16. |
| TAK-831 300 mg | EXPERIMENTAL | TAK-831 300 mg, tablets, orally, QD on Days 1 and 3 to 16. |
| TAK-831 600 mg | EXPERIMENTAL | TAK-831 600 mg, tablets, orally, QD on Days 1 and 3 to 16. |
| TAK-831 15 mg | EXPERIMENTAL | TAK-831 15 mg, suspension, orally, multiple doses (MD) daily, on Days 1 and 3 to 16. |
| TAK-831 800 mg | EXPERIMENTAL | TAK-831 800 mg, suspension, orally, QD on Day 1, MD on Days 3 to 16. |
| TAK-831 1200 mg | EXPERIMENTAL | TAK-831 1200 mg, suspension, orally, QD on Day 1, MD on Days 3 to 16. |
| Name | Type | Description |
|---|---|---|
| TAK-831 T2 | DRUG | TAK-831 T2 Tablets. |
| TAK-831 T3 | DRUG | TAK-831 T3 Tablets. |
| TAK-831 Tablet T2 | DRUG | Tak-831 tablets. |
| Placebo | DRUG | TAK-831 placebo-matching suspension. |
| TAK-831 Suspension | DRUG | TAK-831 Suspension. |
Inclusion Criteria: 1\. Body mass index (BMI) greater than or equal to (\>=) 18.0 and less than (\<) 30.0 kilogram per square meter (kg/m\^2), at Screening. Exclusion Criteria: 1. History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing. 2. Smokes more tha...
TAK-831 T2 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in early clinical development. The completed Phase 1 trials evaluated its safety, tolerability, pharmacokinetics, and the effect of food on its tablet formulations in healthy participants.
TAK-831 T2 is being developed by Neurocrine Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker NBIX. The company is conducting early-stage clinical trials to evaluate the drug's safety and pharmacokinetic profile in healthy participants.
TAK-831 T2 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, both involving healthy volunteers, and no later-phase trials are currently listed.
TAK-831 T2 has been studied in two completed Phase 1 trials. NCT03224325 evaluated safety, tolerability, and pharmacokinetics of escalating multiple doses in 50 healthy participants. NCT03706469 assessed relative bioavailability and food effects on tablet formulations in 16 healthy volunteers. Both were conducted in the United States.
TAK-831 T2 is a formulation or version of the compound TAK-831. The clinical trials listed for TAK-831 T2 use the name TAK-831 in their titles, indicating they refer to the same drug substance. The 'T2' designation may distinguish a specific tablet formulation being developed.