Human VolunteersPhase 1NCT01776437
Study of BMN 673, a PARP Inhibitor, in Healthy Adult Male Volunteers
A Phase 1 study testing BMN 673 in people with Human Volunteers, run by Pfizer at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Volunteers
- What is being tested?
- BMN 673
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jul 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit Inc.
Evansville, Indiana, 47710
About this study
Official title: 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.
- Conditions
- Human Volunteers
- Being tested
- BMN 673
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMN 673Drug
500mcg dose of BMN 673, 2 discrete single doses separated by 21 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Period 1: fasted control → Period 2: fed control Receives: Drug: BMN 673 |
| Treatment B | Experimental | Period 1: fed control → Period 2: fasted control Receives: Drug: BMN 673 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionMay 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human VolunteersStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776437
- Sponsor's protocol ID
- 673-103
- Status last verified
- Jul 2017
- First submitted
- 24 Jan 2013
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Food Effect Study of BMN 673 Administered to Healthy Adult Male Volunteers
- ClinicalTrials.gov ID
- NCT01776437
- Acronym / sponsor ID
- 673-103
- Conditions
- Human Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 28 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: BMN 673Period 1: fasted control → Period 2: fed control |
| Treatment B | Experimental | Drug: BMN 673Period 1: fed control → Period 2: fasted control |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMN 673500mcg dose of BMN 673, 2 discrete single doses separated by 21 days | Drug | Treatment A, Treatment B |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMN 673 in people with Human Volunteers, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.