HIV InfectionsPhase 1NCT02206711
Study of the Absorption, Metabolism, and Route of Elimination of a Novel Class of Anti-HIV 1 Drugs (BMS-955176) in Humans.
A Phase 1 study testing BMS-955176 in people with HIV Infections, run by ViiV Healthcare at 1 site in United States.
Trial summary
The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and extent of elimination, safety and tolerability of a single oral dose of [14C] BMS-955176 in healthy male subjects. There is no formal research hypothesis to be statistically tested for this study. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- BMS-955176
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2014to 9 Sep 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Male subjects
- Ages 18-50 years
- Body weight of at least 110 lbs (50kg)
- BMI of 18 to 32 kg/m^2
- non-smoking
Who cannot join
- Clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months (eg serial X-ray or CAT scans, barium meals).
- gastrointestinal disease including gastrointestinal surgery
- constipation or irregular bowel movements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics and Metabolism of [14C] BMS-955176 in Healthy Male Subjects
The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and extent of elimination, safety and tolerability of a single oral dose of [14C] BMS-955176 in healthy male subjects. There is no formal research hypothesis to be statistically tested for this study.
- Conditions
- HIV Infections
- Being tested
- BMS-955176
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-955176Drug
Single dose of drug on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Single oral dose of [14C] BMS 955176 | Experimental | A single 180 mg oral dose of [14C] BMS-955176 containing approximately 80 microcurie of total radioactivity. Receives: Drug: BMS-955176 |
| Nasoduodenal (ND) Tube Cohort | Experimental | A single dose of [14C] BMS 955176 on Day 1 with ND placement 1 hour post dose to facilitate continuous bile collection though 8 hours post dose. Receives: Drug: BMS-955176 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To asses the PK (AUC, Cmax) of a single oral dose
Serial blood samples for PK parameters determined from plasma concentration versus time
Measured: Day 1 through Day 13 (predose to 288 hours)
To estimate extent of elimination of a single oral dose (% TRA recovery)
Sample of urinary/fecal/bile will be collected for determining total recovery.
Measured: Day 1 through Day 13 (predose to 288 hours)
Secondary outcomes (1)
Safety Assessment
Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.
Measured: Day 1 through Day 13
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 start8 Aug 2014
- Primary completion9 Sep 2014
- Study completion9 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Viiv Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206711
- Sponsor's protocol ID
- 206291
- Other IDs
- AI468-036
- Status last verified
- Apr 2018
- First submitted
- 30 Jul 2014
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Metabolism of [14C] BMS-955176 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02206711
- Acronym / sponsor ID
- 206291
- Conditions
- HIV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 8 Aug 2014 (actual)
- Primary completion
- 9 Sep 2014 (actual)
- Study completion
- 9 Sep 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.
The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and extent of elimination, safety and tolerability of a single oral dose of [14C] BMS-955176 in healthy male subjects. There is no formal research hypothesis to be statistically tested for this study.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single oral dose of [14C] BMS 955176 | Experimental | Drug: BMS-955176A single 180 mg oral dose of [14C] BMS-955176 containing approximately 80 microcurie of total radioactivity. |
| Nasoduodenal (ND) Tube Cohort | Experimental | Drug: BMS-955176A single dose of [14C] BMS 955176 on Day 1 with ND placement 1 hour post dose to facilitate continuous bile collection though 8 hours post dose. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy Male subjects
- Ages 18-50 years
- Body weight of at least 110 lbs (50kg)
- BMI of 18 to 32 kg/m^2
- non-smoking
Key exclusion criteria (3 listed)
- Clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months (eg serial X-ray or CAT scans, barium meals).
- gastrointestinal disease including gastrointestinal surgery
- constipation or irregular bowel movements
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 |
|---|---|---|
| BMS-955176Single dose of drug on Day 1 | Drug | Nasoduodenal (ND) Tube Cohort, Single oral dose of [14C] BMS 955176 |
Primary outcome
To asses the PK (AUC, Cmax) of a single oral dose
Time frame: Day 1 through Day 13 (predose to 288 hours)
Serial blood samples for PK parameters determined from plasma concentration versus time
To estimate extent of elimination of a single oral dose (% TRA recovery)
Time frame: Day 1 through Day 13 (predose to 288 hours)
Sample of urinary/fecal/bile will be collected for determining total recovery.
1 secondary outcome
Safety Assessment
Time frame: Day 1 through Day 13
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 17 Apr 2018.
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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.
Viiv Clinical Trials study director
ViiV Healthcare
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 BMS-955176 in people with HIV Infections, run by ViiV Healthcare 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 5 inclusion and 3 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 17 Apr 2018. 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?
To asses the PK (AUC, Cmax) of a single oral dose (time frame: Day 1 through Day 13 (predose to 288 hours)). The study lists 2 primary outcomes in all. 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 17 Apr 2018.