Study of BMN 673, a PARP Inhibitor, in Healthy Adult Male Volunteers

Human Volunteers Clinical Trial

Official title:

A Phase 1 Food Effect Study of BMN 673 Administered to Healthy Adult Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01776437
• Other study ID #: 673-103
• Status: Completed
• Phase: Phase 1
• First received: January 24, 2013
• Last updated: July 26, 2017
• Start date: February 2013
• Est. completion date: July 2013

Study information

• Verified date: July 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Human Volunteers

Intervention

Drug:
• BMN 673
500mcg dose of BMN 673, 2 discrete single doses separated by 21 days

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit Inc.	Evansville	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

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