HIV-infection/AIDSPhase 1NCT01827540
Study of Dolutegravir (DTG) on PK of Cenicriviroc (CVC), and CVC on PK of DTG & on a Single Dose of Midazolam
A Phase 1 study testing Cenicriviroc, Dolutegravir and Midazolam in people with HIV-infection/AIDS, run by Tobira Therapeutics, Inc. at 1 site in United States.
Trial summary
To evaluate the PK, safety and tolerability of Cenicriviroc (CVC) administered with and without Dolutegravir (DTG) and CVC with and without a single dose of Midazolam in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV-infection/AIDS
- What is being tested?
- Cenicriviroc, Dolutegravir and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to May 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provide written informed voluntary consent
- Adult male and female healthy volunteers
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2.
- Be in good general health with no clinically relevant abnormalities
- Agree to comply with study procedures and restrictions
Who cannot join
- Any disease or condition that might affect drug absorption, metabolism, or excretion, or clinically significant cardiovascular as determined by investigator
- History of stomach or intestinal surgery, except for fully healed appendectomy and/or cholecystectomy which will be allowed
- Clinically significant illness or clinically significant surgery within 4 weeks before the administration of study medication
- Known or suspected hypersensitivity or allergic reaction to any of the components of CVC or DTG tablets, or midazolam syrup
- Serum ALT, AST, or bilirubin values greater than or equal to Division of Acquired Immunodeficiency Syndrome (DAIDS) grade 1 at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Multiple-Dose, Open-Label, Crossover Study in Healthy Subjects to Assess the Effect of Dolutegravir (DTG) on the Pharmacokinetics (PK) of Cenicriviroc (CVC) and the Effect of CVC on the PK of DTG and on a Single Dose of Midazolam
To evaluate the PK, safety and tolerability of Cenicriviroc (CVC) administered with and without Dolutegravir (DTG) and CVC with and without a single dose of Midazolam in healthy subjects.
Read the detailed description
Primary Objectives
- To evaluate the steady-state PK of CVC administered with and without DTG .
- To evaluate the steady-state PK of DTG administered with and without CVC .
- To evaluate the PK of a single dose of Midazolam administered with and without steady state CVC when both are administered orally.
Secondary Objectives
- To evaluate the safety and tolerability of CVC administered with and without DTG.
- To evaluate the safety and tolerability of CVC administered with and without Midazolam.
- Conditions
- HIV-infection/AIDS
- Being tested
- Cenicriviroc, Dolutegravir, Midazolam
- Keywords
- HIV/AIDS, Cenicriviroc (CVC), Dolutegravir (DTG), Midazolam, Healthy Subjects
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CenicrivirocDrug
Also called CVC
DolutegravirDrug
Also called DTG
MidazolamDrug
Also called Dormicum, Hypnovel, Versed
| Study group | Role | What they receive |
|---|---|---|
| Cenicriviroc + Midazolam, and CVC + DTG | Experimental | Grp 1: CVC 150mg qd alone from Days 1-10; CVC 150mg qd + DTG 50mg qd from Days 11-20. A single dose of midazolam 5mg administered alone on Day -1 \& w/ CVC 150mg on Day 9. Receives: Drug: Cenicriviroc; Drug: Dolutegravir; Drug: Midazolam |
| Dolutegravir , and DTG + CVC | Experimental | Grp 2: DTG 50 mg qd alone from Days 1-10, DTG 50 mg qd + CVC 150 mg qd from Days 11-20. Receives: Drug: Cenicriviroc; Drug: Dolutegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Assessment of Cenicriviroc
PK profile will be calculated based on CVC exposure. Trough (predose) CVC plasma samples will be obtained prior to dosing on Days 2-9 \& 12-19.
Measured: 0 (predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, & 24 hours postdose on Days 10 and 20
Pharmacokinetic Assessment of Dolutegravir
PK profile will be calculated based on DTG exposure. Trough (predose) DTG plasma samples will be obtained prior to dosing on Days 2-9 \& 12-19.
Measured: 0 (predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, & 24 hours postdose on Days 10 and 20
Pharmacokinetic Assessment of Midazolam and alpha-hydroxymidazolam
PK profile will be calculated (Group 1 only) based on plasma midazolam \& alpha-hydroxymidazolam exposure.
Measured: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 & 18 hours postdose on Day -1 and Day 9
Secondary outcomes (1)
Number of participants with adverse events
Physical examinations, vital signs, ECGs, clinical laboratory tests, and AEs or serious AEs (SAEs) will be assessed at specified time points according to the Schedule of Procedures in the protocol. In addition, arterial oxygen saturation will be monitored by pulse oximetry for at least 2 hours after administration of midazolam on Days -1 and 9 in Group 1.
For both groups, a final follow-up visit will occur 14 days (±3 days) after the last dose of study medication, or at the time of early termination (if applicable) to evaluate any remaining safety issue(s).
Measured: Participants will be followed upon taking first dose of study medication until the follow-up visit, an expected average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-infection/AIDSStudies 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
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tobira Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ViiV Healthcare
- Responsible party
- Sponsor
- Investigators
- Audrey Martinez, MD, Principal investigator, SeaView Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827540
- Sponsor's protocol ID
- TBR 652-1-110
- Status last verified
- Apr 2014
- First submitted
- 25 Mar 2013
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multiple-Dose, Open-Label, Crossover Study in Healthy Subjects to Assess the Effect of Dolutegravir (DTG) on the Pharmacokinetics (PK) of Cenicriviroc (CVC) and the Effect of CVC on the PK of DTG and on a Single Dose of Midazolam
- ClinicalTrials.gov ID
- NCT01827540
- Acronym / sponsor ID
- TBR 652-1-110
- Conditions
- HIV-infection/AIDS
- Keywords
- HIV/AIDS, Cenicriviroc (CVC), Dolutegravir (DTG), Midazolam, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tobira Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ViiV Healthcare
- Study start
- Mar 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 9 Apr 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.
To evaluate the PK, safety and tolerability of Cenicriviroc (CVC) administered with and without Dolutegravir (DTG) and CVC with and without a single dose of Midazolam in healthy subjects.
Detailed description
Primary Objectives
- To evaluate the steady-state PK of CVC administered with and without DTG .
- To evaluate the steady-state PK of DTG administered with and without CVC .
- To evaluate the PK of a single dose of Midazolam administered with and without steady state CVC when both are administered orally.
Secondary Objectives
- To evaluate the safety and tolerability of CVC administered with and without DTG.
- To evaluate the safety and tolerability of CVC administered with and without Midazolam.
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cenicriviroc + Midazolam, and CVC + DTG | Experimental | Drug: Cenicriviroc, Drug: Dolutegravir, Drug: MidazolamGrp 1: CVC 150mg qd alone from Days 1-10; CVC 150mg qd + DTG 50mg qd from Days 11-20. A single dose of midazolam 5mg administered alone on Day -1 \& w/ CVC 150mg on Day 9. |
| Dolutegravir , and DTG + CVC | Experimental | Drug: Cenicriviroc, Drug: DolutegravirGrp 2: DTG 50 mg qd alone from Days 1-10, DTG 50 mg qd + CVC 150 mg qd from Days 11-20. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Provide written informed voluntary consent
- Adult male and female healthy volunteers
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2.
- Be in good general health with no clinically relevant abnormalities
- Agree to comply with study procedures and restrictions
Key exclusion criteria (5 listed)
- Any disease or condition that might affect drug absorption, metabolism, or excretion, or clinically significant cardiovascular as determined by investigator
- History of stomach or intestinal surgery, except for fully healed appendectomy and/or cholecystectomy which will be allowed
- Clinically significant illness or clinically significant surgery within 4 weeks before the administration of study medication
- Known or suspected hypersensitivity or allergic reaction to any of the components of CVC or DTG tablets, or midazolam syrup
- Serum ALT, AST, or bilirubin values greater than or equal to Division of Acquired Immunodeficiency Syndrome (DAIDS) grade 1 at screening
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 |
|---|---|---|
| CenicrivirocAlso: CVC | Drug | Cenicriviroc + Midazolam, and CVC + DTG, Dolutegravir , and DTG + CVC |
| DolutegravirAlso: DTG | Drug | Cenicriviroc + Midazolam, and CVC + DTG, Dolutegravir , and DTG + CVC |
| MidazolamAlso: Dormicum, Hypnovel, Versed | Drug | Cenicriviroc + Midazolam, and CVC + DTG |
Primary outcome
Pharmacokinetic Assessment of Cenicriviroc
Time frame: 0 (predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, & 24 hours postdose on Days 10 and 20
PK profile will be calculated based on CVC exposure. Trough (predose) CVC plasma samples will be obtained prior to dosing on Days 2-9 \& 12-19.
Pharmacokinetic Assessment of Dolutegravir
Time frame: 0 (predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, & 24 hours postdose on Days 10 and 20
PK profile will be calculated based on DTG exposure. Trough (predose) DTG plasma samples will be obtained prior to dosing on Days 2-9 \& 12-19.
Pharmacokinetic Assessment of Midazolam and alpha-hydroxymidazolam
Time frame: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 & 18 hours postdose on Day -1 and Day 9
PK profile will be calculated (Group 1 only) based on plasma midazolam \& alpha-hydroxymidazolam exposure.
1 secondary outcome
Number of participants with adverse events
Time frame: Participants will be followed upon taking first dose of study medication until the follow-up visit, an expected average of 5 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 9 Apr 2014.
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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.
Audrey Martinez, MD principal investigator
SeaView Research, Inc.
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 Cenicriviroc, Dolutegravir and Midazolam in people with HIV-infection/AIDS, run by Tobira Therapeutics, 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 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 9 Apr 2014. 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?
Pharmacokinetic Assessment of Cenicriviroc (time frame: 0 (predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, & 24 hours postdose on Days 10 and 20). The study lists 3 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 9 Apr 2014.