HealthyPhase 1NCT02205905
An Open-label, Single-dose, Non-randomized Study of IV 14C-labeled PER977 in Healthy Male Subjects
A Phase 1 study testing 14C PER977 in people with Healthy, run by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This is an open-label, single-dose, non-randomized study in healthy male subjects to characterize the mass balance, metabolic disposition, and identification of the metabolites and general metabolic pathways following administration of a single dose of IV solution containing 200 mg of PER977 plus a tracer amount of… Read more about this study
- Who is it for?
- Ages 15 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 14C PER977
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Aug 2014
- 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 15 to 55 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male
- 18-55 years of age (inclusive)
- Body mass index 18-32 kg/m2 (inclusive) and a minimum of 50 kg (110 lbs)
- voluntarily consent to participate and provide written informed consent prior to start of study specific procedures
- Willing and able to remain in the study unit for the entire duration of the confinement period
- Willing to collect all urine and fecal samples for the duration of the study period as required
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- Will to eat entire meals and snacks provided during confinement at the research facility, and understand diet will include foods with high fiber content and possibly prune juice
- Willing to use a waterless commode located in a designated dry room for urine and feces collection for the duration of the study period as required
- Willing to abstain from showering for the first 72 hours following study drug administration. After the restriction is lifted, willing to provide a urine sample prior to showering for the remainder of the confinement period.
Who cannot join
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any condition which, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results
- Clinically significant abnormal finding on the physical exam, medical history, electrocardiogram or clinical laboratory resutls at screening
- History or presence of allergic or adverse response to anticoagulant reversal agents or related drugs
- Significantly abnormal diet within 4 weeks
- Donated blood or plasma within 30 days
- Participated in another clinical trial (randomized subjects only) within 30 days
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- Participated in a radiolabeled clinical trial within the last 12 months
- Used any over-the-counter medication, including nutritional supplements, within 7 days
- Used any prescription medication within 14 days prior
- Treated with any known drugs that are moderate or strong inhibitors/inducers of CYP enzymes such as barbiturates,phenothiazines, cimetidine, carbamazepine, etc. within 30 days
- Smoked or used tobacco products within 60 days
- History of substance abuse or treatment (including alcohol ) within the past 2 years
- Positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates) or cotinine at screening or check-in
- Positive test for hepatitis B surface antigen, hepatitis C antibody or human immunodeficiency virus at screening or has previously been treated for hepatitis B, hepatitis C or HIV infection
- Has irregular bowel habits
- Has had significant radiation exposure within the prior 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Worldwide Clinical Trials Early Phase Services
San Antonio, Texas, 78217
About this study
Official title: An Open-label, Single-dose, Non-randomized Study of the Absorption, Metabolism, and Excretion of Intravenously Administered 14C-labeled PER977 in Healthy Male Subjects
This is an open-label, single-dose, non-randomized study in healthy male subjects to characterize the mass balance, metabolic disposition, and identification of the metabolites and general metabolic pathways following administration of a single dose of IV solution containing 200 mg of PER977 plus a tracer amount of 14C PER977 in health male subjects.
- Conditions
- Healthy
- Being tested
- 14C PER977
- Keywords
- PER977, metabolic disposition, mass balance, metabolites, radiolabeled
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14C PER977Drug
Also called ciraprantag
Open-label, single dose
| Study group | Role | What they receive |
|---|---|---|
| 14C PER977 | Experimental | Open-label, single-dose, non-randomized study of 14C PER977 in six healthy male subjects Receives: Drug: 14C PER977 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass balance of PER977 and metabolite
To characterize the mass balance, metbaolic disposition, and identification of the metabolites and general metabolic pathways following administration of a single dose of IV solution containing 200 mg of PER977 plus a tracer amount of 14C PER977 to healthy male subjects
Measured: 3 weeks
Secondary outcomes (1)
Number of subjects with adverse events
To assess the safety and tolerability of a single intravenous dose of 200 mg PER977
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- World Wide Clinical Trials Early Phase Services, LLC
- Responsible party
- Sponsor
- Investigators
- Cynthia A Zamora, MD, Principal investigator, Worldwide Clinical Trials Early Phase Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205905
- Sponsor's protocol ID
- PER977-01-004
- Status last verified
- Sep 2016
- First submitted
- 28 Jul 2014
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose, Non-randomized Study of the Absorption, Metabolism, and Excretion of Intravenously Administered 14C-labeled PER977 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02205905
- Acronym / sponsor ID
- PER977-01-004
- Conditions
- Healthy
- Keywords
- PER977, metabolic disposition, mass balance, metabolites, radiolabeled
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- World Wide Clinical Trials Early Phase Services, LLC
- Study start
- Jul 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 1 Aug 2014 (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 an open-label, single-dose, non-randomized study in healthy male subjects to characterize the mass balance, metabolic disposition, and identification of the metabolites and general metabolic pathways following administration of a single dose of IV solution containing 200 mg of PER977 plus a tracer amount of 14C PER977 in health male subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 14C PER977 | Experimental | Drug: 14C PER977Open-label, single-dose, non-randomized study of 14C PER977 in six healthy male subjects |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Male
- 18-55 years of age (inclusive)
- Body mass index 18-32 kg/m2 (inclusive) and a minimum of 50 kg (110 lbs)
- voluntarily consent to participate and provide written informed consent prior to start of study specific procedures
- Willing and able to remain in the study unit for the entire duration of the confinement period
Key exclusion criteria (16 listed)
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any condition which, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results
- Clinically significant abnormal finding on the physical exam, medical history, electrocardiogram or clinical laboratory resutls at screening
- History or presence of allergic or adverse response to anticoagulant reversal agents or related drugs
- Significantly abnormal diet within 4 weeks
- Donated blood or plasma within 30 days
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 |
|---|---|---|
| 14C PER977Also: ciraprantagOpen-label, single dose | Drug | 14C PER977 |
Primary outcome
Mass balance of PER977 and metabolite
Time frame: 3 weeks
To characterize the mass balance, metbaolic disposition, and identification of the metabolites and general metabolic pathways following administration of a single dose of IV solution containing 200 mg of PER977 plus a tracer amount of 14C PER977 to healthy male subjects
1 secondary outcome
Number of subjects with adverse events
Time frame: 3 weeks
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 20 May 2020.
- Individual participant dataSharing planned: No
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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.
Cynthia A Zamora, MD principal investigator
Worldwide Clinical Trials Early Phase Services
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 14C PER977 in people with Healthy, run by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc. 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 9 inclusion and 16 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 20 May 2020. 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?
Mass balance of PER977 and metabolite (time frame: 3 weeks). 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 20 May 2020.