HIV InfectionsPhase 1NCT02674581

A Study of the Pharmacokinetics and Safety of BMS-663068 Administered in Subjects With Normal Renal Function and With Mild, Moderate, Severe and End Stage Renal Dysfunction (ESRD)

A Phase 1 study testing Oral BMS-663068 (pro-drug) in people with HIV Infections, run by ViiV Healthcare at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

An oral dose in healthy and renally impaired subjects to determine the drug effect for BMS-663068. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: HIV Infections
What is being tested?: Oral BMS-663068 (pro-drug)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 26 Feb 2016to 24 May 2016
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Classification by renal function based on eGFR
Clinical, ECG, and laboratory findings consistent with renal dysfunction
BMI of 18.0 to 38.0 kg/m2 inclusive
Women of child bearing potential (WOCBP) and sexually active fertile men with partners who are WOCBP must use non-hormonal highly effective birth control
Slightly different inclusion criteria are defined in the protocol for healthy subjects

Who cannot join

History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening
Evidence of rapidly deteriorating renal function, defined as a screening eGFR that has decreased from a previous eGFR by ≥ 50% within the last 3 months
Current or recent (within 3 months of study drug administration) clinically significant gastrointestinal disease or gastrointestinal surgery (including cholecystectomy) that could impact the absorption of study drug
Any major surgery within 4 weeks of study drug administration.
Other protocol defined exclusion criteria could apply

Trial locations and contacts

1 site in 1 country.

United States1 site

GSK Investigational Site
Miami, Florida, 33014

Other trials in United States

About this study

Official title: An Open-label Study to Evaluate the Pharmacokinetics and Safety of BMS-663068 in Subjects With Normal Renal Function and Subjects With Mild, Moderate, Severe, and End-Stage Renal Dysfunction

An oral dose in healthy and renally impaired subjects to determine the drug effect for BMS-663068.

Conditions: HIV Infections
Being tested: Oral BMS-663068 (pro-drug)
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oral BMS-663068 (pro-drug)Drug
Oral BMS-663068 (pro-drug), metabolized to active BMS-626529

Study groups in NCT02674581
Study group	Role	What they receive
Healthy Subjects	Experimental	A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1. Receives: Drug: Oral BMS-663068 (pro-drug)
Mild Renal Impairment Subjects	Experimental	A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1. Receives: Drug: Oral BMS-663068 (pro-drug)
Moderate Renal Impairment Subjects	Experimental	A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1. Receives: Drug: Oral BMS-663068 (pro-drug)
Severe Renal Impairment Subjects	Experimental	A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1. Receives: Drug: Oral BMS-663068 (pro-drug)
End Stage Renal Disease Subjects	Experimental	A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1. Receives: Drug: Oral BMS-663068 (pro-drug)

What is being measured

The primary outcome is the main question the study is designed to answer.

Effect of Renal Impairment on The Primary Endpoints of Cmax
To assess the effect of varying degrees of renal impairment on the exposure of BMS-626529 after a single oral-dose administration of the pro-drug, BMS-663068, will be evaluated by assessing the primary endpoints of Cmax, for BMS-626529.
Measured: Day 1 - Day 5

Secondary outcomes (1)

Safety and Tolerability as assessed by the Incidence of Serious Adverse Events (SAEs), Adverse Events (AEs), AEs leading to discontinuation, and the results of ECGs, vital signs, physical examination, and clinical laboratory tests.
To assess the safety and tolerability of BMS-663068 in subjects with normal renal function and subjects with impaired renal functions, will be measured by the following secondary endpoints: Incidence of AEs, Serious Adverse Events (SAEs), and AEs leading to discontinuation, and results of vital signs, ECGs, physical examination, and clinical laboratory tests.
Measured: Day 1 - Day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Feb 201624 May 2016

First posted4 Feb 2016 (estimated)
Study start26 Feb 2016
Primary completion24 May 2016
Study completion24 May 2016

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: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02674581
Sponsor's protocol ID: 206217
Other IDs: AI438-070
Status last verified: May 2018
First submitted: 21 Dec 2015
Last updated: 15 May 2018
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Study to Evaluate the Pharmacokinetics and Safety of BMS-663068 in Subjects With Normal Renal Function and Subjects With Mild, Moderate, Severe, and End-Stage Renal Dysfunction
ClinicalTrials.gov ID: NCT02674581
Acronym / sponsor ID: 206217
Conditions: HIV Infections
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: ViiV HealthcareIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: 26 Feb 2016 (actual)
Primary completion: 24 May 2016 (actual)
Study completion: 24 May 2016 (actual)
First posted: 4 Feb 2016 (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.

An oral dose in healthy and renally impaired subjects to determine the drug effect for BMS-663068.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Healthy Subjects	Experimental	Drug: Oral BMS-663068 (pro-drug)A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
Mild Renal Impairment Subjects	Experimental	Drug: Oral BMS-663068 (pro-drug)A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
Moderate Renal Impairment Subjects	Experimental	Drug: Oral BMS-663068 (pro-drug)A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
Severe Renal Impairment Subjects	Experimental	Drug: Oral BMS-663068 (pro-drug)A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
End Stage Renal Disease Subjects	Experimental	Drug: Oral BMS-663068 (pro-drug)A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Classification by renal function based on eGFR
Clinical, ECG, and laboratory findings consistent with renal dysfunction
BMI of 18.0 to 38.0 kg/m2 inclusive
Women of child bearing potential (WOCBP) and sexually active fertile men with partners who are WOCBP must use non-hormonal highly effective birth control
Slightly different inclusion criteria are defined in the protocol for healthy subjects

Key exclusion criteria (5 listed)

History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening
Evidence of rapidly deteriorating renal function, defined as a screening eGFR that has decreased from a previous eGFR by ≥ 50% within the last 3 months
Current or recent (within 3 months of study drug administration) clinically significant gastrointestinal disease or gastrointestinal surgery (including cholecystectomy) that could impact the absorption of study drug
Any major surgery within 4 weeks of study drug administration.
Other protocol defined exclusion criteria could apply

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
Oral BMS-663068 (pro-drug)Oral BMS-663068 (pro-drug), metabolized to active BMS-626529	Drug	End Stage Renal Disease Subjects, Healthy Subjects, Mild Renal Impairment Subjects, Moderate Renal Impairment Subjects, Severe Renal Impairment Subjects

Primary outcome

Effect of Renal Impairment on The Primary Endpoints of Cmax
Time frame: Day 1 - Day 5
To assess the effect of varying degrees of renal impairment on the exposure of BMS-626529 after a single oral-dose administration of the pro-drug, BMS-663068, will be evaluated by assessing the primary endpoints of Cmax, for BMS-626529.

1 secondary outcome

Safety and Tolerability as assessed by the Incidence of Serious Adverse Events (SAEs), Adverse Events (AEs), AEs leading to discontinuation, and the results of ECGs, vital signs, physical examination, and clinical laboratory tests.
Time frame: Day 1 - Day 5

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 15 May 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.

GSK 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 Oral BMS-663068 (pro-drug) 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 5 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 15 May 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?

Effect of Renal Impairment on The Primary Endpoints of Cmax (time frame: Day 1 - Day 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02674581.

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 15 May 2018.