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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: TG-2349 as the original formulation; Drug: TG-2349 as a new capsule formulation

• Registration Number: NCT02108418
• Lead Sponsor: TaiGen Biotechnology Co., Ltd.

Brief 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.

Study Timeline

• Study First Submitted: 2014-03-27
• Study Start: 2014-04
• Study First Submitted QC: 2014-04-06
• Study First Posted: 2014-04-09
• Primary Completion: 2014-06
• Study Completion: 2014-07
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-18
• Last Update Posted: 2014-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TG-2349 as the original formulation	TG-2349 as the original formulation	400 mg, 2 syringes
TG-2349 as a new capsule formulation	TG-2349 as a new capsule formulation	400 mg, 4 capsules

Primary Outcome Measures

Name	Time	Method
Primary pharmacokinetic parameters: AUC0-t, AUC0-inf and Cmax	120 hours after administration of study drug in each session

Secondary Outcome Measures

Name	Time	Method
Secondary pharmacokinetic parameters:Tmax, t1/2, CL/F, V/F and λz	120 hours after administration of study drug in each session
Urine pharmacokinetic parameters: Urine Ae%	120 hours after administration of study drug in each session
Stool pharmacokinetic parameters: Stool Ae%	120 hours after administration of study drug in each session
Safety parameters: Incidence and severity of AEs, changes from baseline in safety laboratory values, 12-lead ECG parameters, vital signs, and physical examination.	approximately 7 weeks

Trial Locations

Locations (1)

WCCT; 🇺🇸 Cypress, California, United States