Food Effect Clinical Trial
— HMPL-504Official title:
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
Verified date | December 2013 |
Source | Hutchison Medipharma Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | June 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Males , between 18 and 45 years of age, inclusive. - Body mass index (BMI) within the range of 19 to 25 kg/m2, inclusive. - In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs. - Adequate hepatic, renal, heart, and hematologic functions - Male subjects who are either sterile or agree to use, during the period from informed consent until 90 days following Study Completion, 1 of the following approved methods of contraception: a double barrier method (eg, male condom with spermicide, use by female sexual partner of an intrauterine device with spermicide, a female condom with spermicide, contraceptive sponge with spermicide, a diaphragm with spermicide, or use of a cervical cap with spermicide); a sterile sexual partner; a female sexual partner using an intravaginal system (eg,NuvaRing®); or a partner using an oral, implantable, transdermal, or injectable contraceptives. - Able to comprehend and willing to sign an informed consent form (ICF). Exclusion Criteria: - Significant history or clinical manifestation of any significant metabolic/endocrine, allergic, dermatological, hepatic, renal, hematological, pulmonary, immune, cardiovascular, gastrointestinal, genitourinary, neurological, or psychiatric disorder(as determined by the Investigator). - History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator. - History of stomach or intestinal surgery, nephrectomy, cholecystectomy or resection that would potentially alter absorption and/or excretion of orally administered drugs as determined by the investigator (appendectomy and/or hernia repair may be allowed). - History or presence of an abnormal ECG, which, in the Investigator's opinion, is clinically significant. - Diagnosis of alcoholism or drug addiction within 1 year prior to Period 1 Check-in. - Participation in any other investigational drug study in which receipt of an investigational study drug occurred within 5 half-lives or 30 days, whichever is longer prior to informed consent. - Use of any prescription medications or products within 14 days prior to Period 1 prior to informed consent. - Use of any over-the-counter (OTC), non-prescription preparations (including vitamins, minerals, and phytotherapeutic, herbal, dietary supplements, or plant derived preparations) within 7 days prior to each study period Check-in. - Use of alcohol-, grapefruit-, Seville orange-, or caffeine-containing foods, juices, or beverages within 72 hours prior to each study period Check-in. - Use of known hepatic or renal clearance altering agents (eg, erythromycin, cimetidine, barbiturates, phenothiazines, or herbal/plant derived preparations such as St. John's Wort, etc.) for a period of 60 days prior to informed consent; - Poor peripheral venous access. - Donation of blood = 250 mL from 30 days prior to informed consent until study completion, inclusive, or of plasma from 2 weeks prior to informed consent until study completion, inclusive. - Receipt of blood products within 2 months prior to Period 1 Check-in; - Blood pressure greater than 140/90 mmHg confirmed by repeat at Screening or at Period 1 Check-in. - Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Xuhui Central Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Hutchison Medipharma Limited |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Urinal and fecal excretion ratio of Volitnib;renal clearance of Volitinib | 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 | duriation the first day to the third day after every drug administration | |
Primary | pharmacokinetics | 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 | 1-3days after every drug administration | |
Secondary | Safety | AE(adverse event) will be summarized by type and severity | 1 day to the 14days after every drug administration |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04501640 -
A Study to Investigate the Effect of Food With Mirabegron in Healthy Chinese Participants
|
Phase 4 | |
Completed |
NCT01224587 -
Magnetic Marker Monitoring (MMM) Study With Gel Matrix Tablets Under Fasting and Fed Conditions
|
Phase 1 | |
Withdrawn |
NCT02560363 -
A Study to Compare the Pharmacokinetics of Different Formulations of AZD9977 and the Influence of Food in Healthy Male Subjects
|
Phase 1 | |
Completed |
NCT03150498 -
A Food Effects Study and Optional Multi Dose Study to Assess PK of BTD-001
|
Phase 1 | |
Completed |
NCT01686217 -
A Phase I Study to Compare 3 Different Strengths of an Extended Release Formulation of ASP015K to an Immediate Release Formulation of ASP015K
|
Phase 1 | |
Completed |
NCT01322464 -
Study to Assess Food Effect on Sativex Bioavailability
|
Phase 1 | |
Completed |
NCT03885778 -
A Food Effect Study of Besifovir in Healthy Subjects
|
Phase 4 | |
Completed |
NCT05690932 -
A Formulation Bridging and Food Effect Study of PBI-200 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT05187169 -
Food Effect of VS-6766 in Healthy Adult Subjects
|
Phase 1 | |
Completed |
NCT05217732 -
Study to Assess the Safety, Tolerability and Pharmacokinetics of ZX-7101A and the Food Effect in Healthy Volunteers
|
Phase 1 |