NCT02108418

Study to Evaluate the PK, Relative Bioavailability and Safety of TG-2349 With Single Oral Dose Under Fed Condition in Healthy Volunteers

A Phase 1, Randomized, Open-label, 2-way Crossover Study in Healthy East Asian and Caucasian Volunteers to Evaluate the Relative Bioavailability of A New Capsule Formulation of TG-2349 Compared to the Original Formulation of TG-2349 Oral Solution

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: TaiGen Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

1. To evaluate the pharmacokinetics (PK) and relative bioavailability of TG-2349, given as a new capsule formulation and as the original formulation of oral solution, after a single oral dose of 400 mg under fed condition in healthy volunteers. 2. To evaluate the safety and tolerability of TG-2349 in healthy volunteers. 3. To evaluate the ethnic differences in PK and safety between East Asian and Caucasian volunteers.

Detailed description

TG-2349 oral solution has been investigated in a phase I/IIa study (study number: TG-2349-01) in healthy volunteers and patients with chronic hepatitis C (CHC) infection. The study demonstrated that TG-2349 was safe and well-tolerated when given to healthy volunteers at single oral doses up to 800 mg, and at five-consecutive daily oral doses up to 600 mg. Co-administration of TG-2349 with food resulted in a significant increase in bioavailability, and therefore concomitant food intake with dosing is recommended. To further advance the clinical development of TG-2349, a new capsule formulation was developed to replace the current TG-2349 oral solution. The objectives of this study (study number: TG-2349-02) are to evaluate the PK and relative bioavailability of TG-2349, given as a new capsule formulation and as the original formulation of oral solution, after a single oral dose of 400 mg under fed condition in healthy volunteers, and to evaluate the safety, tolerability, and ethnic differences of the TG-2349 capsule formulation.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	TG-2349 as the original formulation	single oral dose under fed condition
DRUG	TG-2349 as a new capsule formulation	single oral dose under fed condition

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-06-01
• Completion: 2014-07-01
• First posted: 2014-04-09
• Last updated: 2014-12-19

Locations

1 site across 1 country: United States