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

NCT04705922 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-01-03

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

TT-00420 Capsule

TT-00420 capsule formulation, administered orally

DRUG

TT-00420 Tablet

TT-00420 tablet formulation, administered orally

Sponsors & Collaborators

  • TransThera Sciences (Nanjing), Inc.

    lead INDUSTRY

Principal Investigators

  • Mohamed Al-Ibrahim · Pharmaron CPC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-29
Primary Completion
2021-03-07
Completion
2021-07-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04705922 on ClinicalTrials.gov