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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01776437
Other study ID # 673-103
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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