Effect of a High-fat Meal on the Pharmacokinetics of Hetrombopag and Mass Balance Study in Healthy Subjects
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Mar 2014
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 1, 2015
CompletedFirst Posted
Study publicly available on registry
April 6, 2015
CompletedApril 6, 2015
April 1, 2015
1 month
April 1, 2015
April 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
The maximum plasma concentration (Cmax) of hetrombopag
Cmax (a measure of the body's exposure to hetrombopag) will be compared under fating state and fasted state
0h-120h
The area under the plasma concentration-time curve (AUC) of hetrombopag
AUC (a measure of the body's exposure to hetrombopag) will be compared under fating state and fasted state
0h-120h
The accumulative excretion rate of hetrombopag and its metabolites in urine and feces
0h-120h
Secondary Outcomes (2)
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
Study Arms (2)
hetrombopag 7.5mg fasted to fed
EXPERIMENTALHetrombopag 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.
hetrombopag 7.5mg fed to fasted
EXPERIMENTALHetrombopag 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.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy.
- Weight≥50 kg，19≤BMI≤28 kg/m2.
- Platelet count is within normal range
You may not qualify if:
- History of clinically significant illness.
- History of alcohol or drug abuse.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West Hospital, Sichuan University
Chengdu, Sichuan, China
Related Publications (1)
Wang Z, Chen X, Li A, Chen L, Wang Y, Zheng L. Effect of Food on the Pharmacokinetic and Pharmacodynamic Profiles of Hetrombopag in Healthy Volunteers. Clin Ther. 2020 Dec;42(12):2280-2288. doi: 10.1016/j.clinthera.2020.10.002. Epub 2020 Oct 24.
PMID: 33109386DERIVED
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2015
First Posted
April 6, 2015
Study Start
March 1, 2014
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
April 6, 2015
Record last verified: 2015-04