CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 25 enrolled
Drug / intervention
TAK-020 Captisol Oral Solution +5 moredrug
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Healthy adult male or female
  • ✓Age 18 to 55 years at informed consent and first dose
  • ✓Weight at least 45 kg; BMI 18–32 kg/m²
Key exclusion· 10
  • ✕Known hypersensitivity to TAK-020, Captisol, or related compounds
  • ✕Positive urine drug screen or positive breath alcohol screen at Screening or Check-in
  • ✕History of drug abuse or alcohol abuse (≥4 units/day) within 1 year, or unwilling to abstain
  • ✕Significant cardiovascular, CNS, hepatic, renal, metabolic, or endocrine disease; serious allergy; asthma; hypertension; seizures; or allergic skin rash

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02723201
NCT02723201Phase 1Completed
CompareCT.gov

A Randomized, Open Label Phase 1 Study in Healthy Volunteers to Evaluate the Relative Bioavailability of a Single Dose of Various Test Solid Formulations of TAK-020 Compared With a Single Dose of Reference Oral Solution and to Evaluate the Food Effect and Potentially the Dose Proportionality of the Optimal Solid Dose Formulation

Takeda·interventional·Posted Mar 30, 2016·Updated Apr 13, 2018

In Brief

A Phase 1 clinical trial evaluating TAK-020 Captisol Oral Solution, TAK-020 CCT, and 3 other interventions for Healthy. Completed, enrolled 25 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the relative bioavailability of solid oral formulations of TAK-020 in comparison with single dose of TAK-020 oral solution formulation and to evaluate the food effect and potentially the dose proportionality of the optimal oral solid formulation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 30, 2016
Enrollment StartApr 28, 2016
Primary CompletionAug 5, 2016
Study CompletionAug 24, 2016
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 10.3 years ago

Interventions

TAK-020 Captisol Oral Solutiondrug

TAK-020 solution.

TAK-020 CCTdrug

TAK-020 co-crystal tablet

TAK-020 SDTdrug

TAK-020 Solid dispersion tablet.

TAK-020 IRTdrug

TAK-020 immediate release tablet.

TAK-020 CCTdrug

TAK-020 co-crystal tablet.

TAK-020 Solid Formulationdrug

TAK-020 solid formulation