A Food Effect Phase I Study of the Volitinib in Healthy Subjects (HMPL-504)
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ClinicalTrials.gov Identifier: NCT02017236 |
Recruitment Status :
Completed
First Posted : December 20, 2013
Last Update Posted : May 14, 2019
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Sponsor:
Hutchison Medipharma Limited
Information provided by (Responsible Party):
Hutchison Medipharma Limited
Tracking Information | ||||
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First Submitted Date ICMJE | November 27, 2013 | |||
First Posted Date ICMJE | December 20, 2013 | |||
Last Update Posted Date | May 14, 2019 | |||
Study Start Date ICMJE | November 2013 | |||
Actual Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
pharmacokinetics [ Time Frame: 1-3days after every drug administration ] The following PK parameters will be derived from the plasma concentration-time profile of Volitinib following administration:Area Under Curve (AUC), both from time zero to time with last observation and from time zero to infinity;;Maximum plasma concentration (Cmax);Time to reach the Cmax (Tmax);Apparent oral Clearance (CL/F);Apparent oral Volume of distribution (Vz/F);Other parameters, such as elimination half-life
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Safety [ Time Frame: 1 day to the 14days after every drug administration ] AE(adverse event) will be summarized by type and severity
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures |
Urinal and fecal excretion ratio of Volitnib;renal clearance of Volitinib [ Time Frame: duriation the first day to the third day after every drug administration ] Urinal and fecal excretion ratio of Volitnib, renal clearance of Volitinib;Preliminary metabolite profiling of Volitnib in healthy subjects, with preliminary understanding of the clearance mechanism of Volitinib in human
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Original Other Pre-specified Outcome Measures | Same as current | |||
Descriptive Information | ||||
Brief Title ICMJE | A Food Effect Phase I Study of the Volitinib in Healthy Subjects | |||
Official Title ICMJE | A Single Center, Open-label, Randomized, Four-Sequence, Four-period Crossover Study to Investigate Food Effect on the Pharmacokinetics of Single Dose of Volitinib in Healthy Subjects | |||
Brief Summary | The purpose of this study is to evaluate to determine the effect of food on the PK of a single dose of 600 mg Volitinib and its two major metabolites in healthy subjects. | |||
Detailed Description | The purpose of this study is to evaluate to determine the effect of food on the PK( pharmacokinetics) of a single dose of 600 mg Volitinib and its two major metabolites in healthy subjects and to assess the safety and tolerability of single doses of 600mg in healthy subjects.This study will be an open-label, randomized, four-period, crossover PK food effect study of Volitinib administered orally at 600 mg. Subjects will be screened for eligibility up to 14 days prior to entry into the study,there will be 4 treatments,2 weeks follow-up. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Health Services Research |
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Condition ICMJE |
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Intervention ICMJE | Drug: Volitinib
600mg Volitinib ,single dose,oral
Other Name: HMPL-504
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
25 | |||
Original Estimated Enrollment ICMJE |
32 | |||
Actual Study Completion Date ICMJE | June 2014 | |||
Actual Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 45 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02017236 | |||
Other Study ID Numbers ICMJE | 2013-504-CH1 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Hutchison Medipharma Limited | |||
Study Sponsor ICMJE | Hutchison Medipharma Limited | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Hutchison Medipharma Limited | |||
Verification Date | December 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |