Study of BMN 673, a PARP Inhibitor, in Healthy Adult Male Volunteers
NCT01776437
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
- 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.
- 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.
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| Descriptive Information | |||
|---|---|---|---|
| Brief Title ICMJE | Study of BMN 673, a PARP Inhibitor, in Healthy Adult Male Volunteers | ||
| Official Title ICMJE | A Phase 1 Food Effect Study of BMN 673 Administered to Healthy Adult Male Volunteers | ||
| Brief Summary | 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. | ||
| Detailed Description | Not Provided | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Phase 1 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Other | ||
| Condition ICMJE | Human Volunteers | ||
| Intervention ICMJE | Drug: BMN 673
500mcg dose of BMN 673, 2 discrete single doses separated by 21 days | ||
| Study Arms ICMJE |
| ||
| Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Actual Enrollment ICMJE | 18 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Actual Study Completion Date ICMJE | July 2013 | ||
| Actual Primary Completion Date | May 2013 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||
| Sex/Gender ICMJE |
| ||
| Ages ICMJE | 18 Years to 55 Years (Adult) | ||
| Accepts Healthy Volunteers ICMJE | Yes | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT01776437 | ||
| Other Study ID Numbers ICMJE | 673-103 | ||
| Has Data Monitoring Committee | No | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Responsible Party | Pfizer | ||
| Study Sponsor ICMJE | Pfizer | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Pfizer | ||
| Verification Date | July 2017 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||