Recent Updates
Recently added Catalysts

TAK-385 T2 Formulation

Phase 1

Healthy Volunteers | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Jul 25, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02396147Bioavailability and Effect of Food on TAK-385 Tablet Formulations in Healthy ParticipantsPHASE1 COMPLETED 54 — — Mar 1, 2015Jun 1, 2015Jul 25, 20161 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Cmax: Maximum Observed Plasma Concentration for TAK-385
Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose
AUC(0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Postdose for TAK-385
Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385
Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose
Secondary Endpoints
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
From Day 1 to 30 days after the last dose of study drug (Up to 51 days total)
Number of Participants With Shifts From Normal at Baseline in Safety Laboratory Values in More Than 1 Participant
Baseline and Days 4, 10, 14, 20, 24 and 26
Percentage of Participants With Electrocardiogram (ECG) Parameters Abnormal and Clinically Significant
Days 1, 11, 21 and 26
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1: T2-A + T4B-B + T4B-CEXPERIMENTALT2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was a 10-day washout period between each dose.
Arm 2: T2-A + T4C-D + T4C-EEXPERIMENTALT2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was 10-day washout period between each dose.
Interventions
NameTypeDescription
TAK-385 T2 FormulationDRUGTAK-385 T2 Formulation tablets
TAK-385 T4 Formulation BDRUGTAK-385 T4 Formulation B tablets
TAK-385 T4 Formulation CDRUGTAK-385 T4 Formulation C tablets
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age 18 to 55 years, inclusive, at the time of consent. 2. Healthy adult male, as determined by a physician evaluation that includes: * Medical history (ie, no clinically significant medical conditions requiring ongoing drug therapy). * Physical examination. * Vital ...

Countries:United States
Unlock Eligibility Criteria