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

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NCT01776437

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Covance Clinical Research Unit Inc.
Evansville, Indiana, 47710 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Human Volunteers
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01776437
Pfizer
Completed
Study of BMN 673, a PARP Inhibitor, in Healthy Adult Male Volunteers

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Pfizer Clinical Trials Contact Center

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[email protected]

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Study of BMN 673, a PARP Inhibitor, in Healthy Adult Male Volunteers
A Phase 1 Food Effect Study of BMN 673 Administered to 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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Human Volunteers
Drug: BMN 673
500mcg dose of BMN 673, 2 discrete single doses separated by 21 days
  • Experimental: Treatment A
    Period 1: fasted control ? Period 2: fed control
    Intervention: Drug: BMN 673
  • Experimental: Treatment B
    Period 1: fed control ? Period 2: fasted control
    Intervention: Drug: BMN 673
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
July 2013
May 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01776437
673-103
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Not Provided
Pfizer
July 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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