NCT04705922

Relative Bioavailability Study and Food Effect Study of TT-00420 (Tinengotinib) Capsule and Tablet Formulations in Healthy Volunteers

A Phase I, Single-Center, Open-Label, 3-Way Crossover, Randomized Single Dose Study to Evaluate the Food Effect on the Pharmacokinetics of TT-00420 Tablet and to Determine the Relative Bioavailability of TT-00420 Tablet Versus TT-00420 Capsule in Adult Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: TransThera Sciences (Nanjing), Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This study is an open-label, 3-way crossover randomized study in adult healthy volunteers to evaluate the relative bioavailability of TT-00420 tablet and capsule formulations and to evaluate food effect on the pharmacokinetics of TT-00420 tablet.

Detailed description

Subjects will be randomized to one of three treatment sequences. Each sequence will contain up to 8 subjects. In each treatment sequence, subjects undergo a baseline/screening period, three treatment periods, and a follow-up visit. Subjects will be administered a single dose of TT-00420 on Day 1 of either TT-00420 tablet under fed condition, TT-00420 tablet under fasting condition, or capsule under fasting condition and crossed over after at least a 14-day washout period.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	TT-00420 Capsule	TT-00420 capsule formulation, administered orally
DRUG	TT-00420 Tablet	TT-00420 tablet formulation, administered orally

Timeline

• Start date: 2020-12-29
• Primary completion: 2021-03-07
• Completion: 2021-07-23
• First posted: 2021-01-12
• Last updated: 2024-01-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study