Human Volunteers Clinical Trial
Official title:
A Phase 1 Food Effect Study of BMN 673 Administered to Healthy Adult Male Volunteers
Verified date | July 2017 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized, 2-period, 2-sequence crossover study to evaluate the effect of food on the relative bioavailability of BMN 673 during fasting and fed conditions in healthy male subjects.
Status | Completed |
Enrollment | 18 |
Est. completion date | July 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Male, between the ages of 18 and 55. - Non-smoking for at least 1 year before Screening. - Willing and able to provide informed consent. - Have a BMI between 18 to 30kg/m2. - Willing and able to comply all study procedures. - Have adequate organ function - Sexually active patients must be willing to use an acceptable method of contraception. Exclusion Criteria: - History of any illness that might confound the results of the study or pose an additional risk in administering study medication to the subject. - Current use of prescription medication or regular treatment with over-the-counter medications. - Consumption of herbal medications or dietary supplements. - Consumption of more that than 3 units of alcoholic beverages per day. - Consumption of more than five 240-mL servings of coffee or other caffeinated beverage. - History of alcohol or drug abuse or addiction within 6 months of study entry. - Participation in a clinical Study involving administration of an investigational drug within 1 month or 5 half lives (whichever is longer). - Donation of any blood or having had a significant loss of blood with 56 days. |
Country | Name | City | State |
---|---|---|---|
United States | Covance Clinical Research Unit Inc. | Evansville | Indiana |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome of this study is to evaluate the effect of food on the relative bioavailability of BMN 673. The Pharmacokinetic analyses of plasma BMN 673 concentration-time will be measured using non-compartmental methods. | 4 months | ||
Secondary | Assess the safety and tolerability of BMN 673 during fasting and fed conditions with the following safety assessments: adverse events, physical examination, vital signs, concomitant medications, clinical laboratory tests and ECG. | 4 months |
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