Trial record 1 of 1 for:
NCT01776437
Study of BMN 673, a PARP Inhibitor, in Healthy Adult Male Volunteers
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01776437 |
Recruitment Status :
Completed
First Posted : January 28, 2013
Last Update Posted : July 28, 2017
|
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
Tracking Information | |||
---|---|---|---|
First Submitted Date ICMJE | January 24, 2013 | ||
First Posted Date ICMJE | January 28, 2013 | ||
Last Update Posted Date | July 28, 2017 | ||
Study Start Date ICMJE | February 2013 | ||
Actual Primary Completion Date | May 2013 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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. [ Time Frame: 4 months ] | ||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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. [ Time Frame: 4 months ] | ||
Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
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 |