NCT03860532

Phase I Clinical Trial in Healthy Male Volunteers

Phase I Randomized,Double-Blind,Placebo-controlled Trial in Healthy Male Voluteers To Examine the Safety,Tolerability,and Pharmacokinetics of HMPL-011 After A Single Dose.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I Randomized,Double-Blind,Placebo-controlled Trial in Healthy Male Voluteers To Examine the Safety,Tolerability,and Pharmacokinetics of HMPL-011 After A Single Dose.

Detailed description

Eligible subjects will randomly recieve 1200 mg tablets (600 mg tablet X 2) or 1200 mg capsules (200 mg capsule X 6) of HMPL-011 under fed and fed circumstance in part 1. In part 2, eight subjects will be enrolled and given 800 mg tablets (400 mg/tablet X 2) every 8 hours daily for 6 days (morning dose only on Day 6).

Conditions

• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
DRUG	HMPL-011 tablets	Eligible subjects will recieve 1200 mg HMPL-011 tablets under fed and diet circumstance.
DRUG	HMPL-011 capsules	Eligible subjects will recieve 1200 mg HMPL-011 capsules under fed and diet circumstance.

Timeline

• Start date: 2011-09-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2019-03-04
• Last updated: 2019-03-05