Skip to main content
OpenTrials
Completed

NCT Number: NCT01776437

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Human Volunteers

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit Inc.

Evansville, Indiana, 47710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMN 673

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 28, 2013
Registry last updated
Jul 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.