Effect of a High-fat Meal on the Pharmacokinetics of Hetrombopag and Mass Balance Study in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Hetrombopag Olamine

• Registration Number: NCT02409394
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

This open-label, randomized, two-period, two-treatment (single doses of 7.5 mg hetrombopag fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of hetrombopag and mass balance study in 12 healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2015-04
• Study First Submitted: 2015-04-01
• Study First Submitted QC: 2015-04-03
• Last Update Submitted: 2015-04-03
• Study First Posted: 2015-04-06
• Last Update Posted: 2015-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• Healthy.
• Weight≥50 kg，19≤BMI≤28 kg/m2.
• Platelet count is within normal range

Exclusion Criteria

• History of clinically significant illness.
• History of alcohol or drug abuse.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
hetrombopag 7.5mg fed to fasted	Hetrombopag Olamine	Hetrombopag tablet with high fat, high calorie breakfast on day 1; 9 days wash-out; Than subjects will be crossover to have hetrombopag tablet, under fasting condition on day 11.
hetrombopag 7.5mg fasted to fed	Hetrombopag Olamine	Hetrombopag tablet, fasting conditions on day 1; 9 days wash-out; Than subjects will be crossover to have hetrombopag tablet with high fat, high calorie breakfast on day 11.

Primary Outcome Measures

Name	Time	Method
The maximum plasma concentration (Cmax) of hetrombopag	0h-120h	Cmax (a measure of the body's exposure to hetrombopag) will be compared under fating state and fasted state
The area under the plasma concentration-time curve (AUC) of hetrombopag	0h-120h	AUC (a measure of the body's exposure to hetrombopag) will be compared under fating state and fasted state
The accumulative excretion rate of hetrombopag and its metabolites in urine and feces	0h-120h

Secondary Outcome Measures

Name	Time	Method
The change of platelet count	On day 2, 4, 6, 8,12, 14 and 16
The number of volunteers with adverse events as a measure of safety and tolerability	up to Day 16

Trial Locations

Locations (1)

West Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China