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Completed

NCT Number: NCT02409394

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

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

West Hospital, Sichuan University

Chengdu, Sichuan, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hetrombopag Olamine

Drug

Primary outcomes

  1. The maximum plasma concentration (Cmax) of hetrombopag

    Time frame: 0h-120h

    Cmax (a measure of the body's exposure to hetrombopag) will be compared under fating state and fasted state

  2. The area under the plasma concentration-time curve (AUC) of hetrombopag

    Time frame: 0h-120h

    AUC (a measure of the body's exposure to hetrombopag) will be compared under fating state and fasted state

  3. The accumulative excretion rate of hetrombopag and its metabolites in urine and feces

    Time frame: 0h-120h

Secondary outcomes

  1. The change of platelet count

    Time frame: On day 2, 4, 6, 8,12, 14 and 16

  2. The number of volunteers with adverse events as a measure of safety and tolerability

    Time frame: up to Day 16

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 6, 2015
Registry last updated
Apr 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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