HealthyPhase 1NCT02685462
Pharmacokinetic and Safety Study of Cenicriviroc and HMG-CoA Reductase Inhibitors, Caffeine and Digoxin
A Phase 1 study testing Rosuvastatin, Atorvastatin and Simvastatin in people with Healthy, run by Tobira Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a Phase 1, Open-Label, 3-Period, Single-sequence, Drug-drug Interaction Study in Healthy Subjects to Assess the Effect of Cenicriviroc on the Pharmacokinetics (PK) of HMG-CoA Reductase Inhibitors [Rosuvastatin (ROS), Atorvastatin (ATO) and Simvastatin (SIM)], Caffeine and Digoxin Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Rosuvastatin, Atorvastatin and Simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2016to 23 Feb 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be informed of the nature of the study and have provided written informed voluntary consent.
- Have a BMI ≥ 18.0 and ≤ 35.0 kg/m2.
- Be in good general health with no clinically relevant abnormalities based on medical history, physical examination, clinical laboratory evaluations (clinical chemistry, hematology, urinalysis), and 12-lead ECG that, in the opinion of the Investigator, would affect subject safety.
- Be able to communicate effectively with the Investigator and other study center personnel and agree to comply with the study procedures and restrictions.
Who cannot join
- Any disease or condition that might affect drug absorption, metabolism, or excretion, or clinically significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease, as determined by the Investigator and, if necessary, the Sponsor's Medical Monitor.
- 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.
- History of GERD, heartburn, or nausea more than once a month, or any similar symptoms requiring the regular use of antacids, or any use of H2 histamine blockers or proton-pump inhibitors over the past 3 months.
- History of achlorhydria, pernicious anemia, or peptic ulcers over the past 6 months.
- Known or suspected hypersensitivity or allergic reaction to any of the components of CVC, ROS, ATO, SIM, Digoxin or Caffeine tablets.
- History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin.
- If female, is pregnant or breast feeding, or has a positive pregnancy test result prior to the first dose of study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Open-Label Study in Healthy Adult Subjects to Assess the Effect of Cenicriviroc Mesylate (CVC) on the Pharmacokinetics (PK) of HMG-CoA Reductase Inhibitors (Rosuvastatin, Atorvastatin and Simvastatin), Caffeine and Digoxin
This is a Phase 1, Open-Label, 3-Period, Single-sequence, Drug-drug Interaction Study in Healthy Subjects to Assess the Effect of Cenicriviroc on the Pharmacokinetics (PK) of HMG-CoA Reductase Inhibitors [Rosuvastatin (ROS), Atorvastatin (ATO) and Simvastatin (SIM)], Caffeine and Digoxin
- Conditions
- Healthy
- Being tested
- Rosuvastatin, Atorvastatin, Simvastatin, Digoxin, Caffeine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Rosuvastatin 20 mg
AtorvastatinDrug
Also called Atorvastatin 20 mg
SimvastatinDrug
Also called Simvastatin 20 mg
DigoxinDrug
Also called Digoxin 0.25 mg
CaffeineDrug
Also called Caffine 200 mg
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Rosuvastatin) | Active comparator | Group 1 (12 subjects) will receive Rosuvastatin on Days 1 and 13. Receives: Drug: Rosuvastatin |
| Group 1 (Digoxin) | Active comparator | Group 1 (12 subjects) will receive Digoxin on Days 1 and 13. Receives: Drug: Digoxin |
| Group 1 (Caffeine) | Active comparator | Group 1 (12 subjects) will receive Caffeine on Days 1 and 13. Receives: Drug: Caffeine |
| Group 2 (Atorvastatin) | Active comparator | Group 2 (12 subjects) will receive Atorvastatin on Days 1 and 13. Receives: Drug: Atorvastatin |
| Cenicriviroc | Experimental | Subjects in Group 1 and Group 2 will receive Cenicriviroc on Days 3-12.
Subjects in Group 3 will receive Cenicriviroc on Days 2-12. Receives: Drug: Rosuvastatin; Drug: Atorvastatin; Drug: Simvastatin; Drug: Digoxin; Drug: Caffeine |
| Group 3 (Simvastatin) | Active comparator | Group 3 (12 subjects) will receive Simvastatin on Days 1 and 12. Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Assessment of ROS, ATO and Digoxin alone and in the presence of CVC, as measured by maximum plasma concentration (Cmax)
Measured: Days 1 and 13
Pharmacokinetic Assessment of SIM alone and in the presence of CVC, as measured by maximum plasma concentration (Cmax)
Measured: Days 1 and 12
Pharmacokinetic Assessment of Caffeine alone and in the presence of CVC, as measured by maximum plasma concentration (Cmax)
Measured: Days 1 and 13
Pharmacokinetic Assessment of ROS, ATO and Digoxin alone and in the presence of CVC, as measured by minimum plasma concentration (Cmin)
Measured: Days 1 and 13
Pharmacokinetic Assessment of ROS, ATO and Digoxin alone and in the presence of CVC, as measured by area under the plasma concentration-time curve (AUC)
Measured: Days 1 and 13
Pharmacokinetic Assessment of SIM alone and in the presence of CVC, as measured by minimum plasma concentration (Cmin)
Measured: Days 1 and 12
Pharmacokinetic Assessment of SIM alone and in the presence of CVC, as measured by area under the plasma concentration-time curve (AUC)
Measured: Days 1 and 12
Pharmacokinetic Assessment of Caffeine alone and in the presence of CVC, as measured by minimum plasma concentration (Cmin)
Measured: Days 1 and 13
Pharmacokinetic Assessment of Caffeine alone and in the presence of CVC, as measured by area under the plasma concentration-time curve (AUC)
Measured: Days 1 and 13
Secondary outcomes (5)
Evaluation of Adverse Events
Evaluate adverse events
Measured: 23 days
Changes from Baseline in Clinical Laboratory Tests
Evaluate changes from baseline in clinical laboratory tests including serum chemistry, and hematology
Measured: Baseline and 23 days
Changes from Baseline in 12-lead ECGs
Evaluate changes from baseline in 12-lead ECGs
Measured: Baseline and 23 days
Changes from Baseline in Vital Signs
Evaluate changes from baseline in vital signs, including blood pressure and pulse rate
Measured: Baseline and 23 days
Changes from Baseline in Physical Examinations
Evaluate changes from baseline in physical examinations
Measured: Baseline and 23 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study start31 Jan 2016
- Primary completion23 Feb 2016
- Study completion23 Feb 2016
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tobira Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Millie Gottwald, PharmD, Study director, Tobira Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685462
- Sponsor's protocol ID
- 652-124
- Status last verified
- Nov 2017
- First submitted
- 3 Feb 2016
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label Study in Healthy Adult Subjects to Assess the Effect of Cenicriviroc Mesylate (CVC) on the Pharmacokinetics (PK) of HMG-CoA Reductase Inhibitors (Rosuvastatin, Atorvastatin and Simvastatin), Caffeine and Digoxin
- ClinicalTrials.gov ID
- NCT02685462
- Acronym / sponsor ID
- 652-124
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Tobira Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jan 2016 (actual)
- Primary completion
- 23 Feb 2016 (actual)
- Study completion
- 23 Feb 2016 (actual)
- First posted
- 18 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.
This is a Phase 1, Open-Label, 3-Period, Single-sequence, Drug-drug Interaction Study in Healthy Subjects to Assess the Effect of Cenicriviroc on the Pharmacokinetics (PK) of HMG-CoA Reductase Inhibitors [Rosuvastatin (ROS), Atorvastatin (ATO) and Simvastatin (SIM)], Caffeine and Digoxin
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Rosuvastatin) | Active comparator | Drug: RosuvastatinGroup 1 (12 subjects) will receive Rosuvastatin on Days 1 and 13. |
| Group 1 (Digoxin) | Active comparator | Drug: DigoxinGroup 1 (12 subjects) will receive Digoxin on Days 1 and 13. |
| Group 1 (Caffeine) | Active comparator | Drug: CaffeineGroup 1 (12 subjects) will receive Caffeine on Days 1 and 13. |
| Group 2 (Atorvastatin) | Active comparator | Drug: AtorvastatinGroup 2 (12 subjects) will receive Atorvastatin on Days 1 and 13. |
| Cenicriviroc | Experimental | Drug: Rosuvastatin, Drug: Atorvastatin, Drug: Simvastatin, Drug: Digoxin, Drug: CaffeineSubjects in Group 1 and Group 2 will receive Cenicriviroc on Days 3-12. Subjects in Group 3 will receive Cenicriviroc on Days 2-12. |
| Group 3 (Simvastatin) | Active comparator | Drug: SimvastatinGroup 3 (12 subjects) will receive Simvastatin on Days 1 and 12. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Be informed of the nature of the study and have provided written informed voluntary consent.
- Have a BMI ≥ 18.0 and ≤ 35.0 kg/m2.
- Be in good general health with no clinically relevant abnormalities based on medical history, physical examination, clinical laboratory evaluations (clinical chemistry, hematology, urinalysis), and 12-lead ECG that, in the opinion of the Investigator, would affect subject safety.
- Be able to communicate effectively with the Investigator and other study center personnel and agree to comply with the study procedures and restrictions.
Key exclusion criteria (8 listed)
- Any disease or condition that might affect drug absorption, metabolism, or excretion, or clinically significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease, as determined by the Investigator and, if necessary, the Sponsor's Medical Monitor.
- 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.
- History of GERD, heartburn, or nausea more than once a month, or any similar symptoms requiring the regular use of antacids, or any use of H2 histamine blockers or proton-pump inhibitors over the past 3 months.
- History of achlorhydria, pernicious anemia, or peptic ulcers over the past 6 months.
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 |
|---|---|---|
| RosuvastatinAlso: Rosuvastatin 20 mg | Drug | Cenicriviroc, Group 1 (Rosuvastatin) |
| AtorvastatinAlso: Atorvastatin 20 mg | Drug | Cenicriviroc, Group 2 (Atorvastatin) |
| SimvastatinAlso: Simvastatin 20 mg | Drug | Cenicriviroc, Group 3 (Simvastatin) |
| DigoxinAlso: Digoxin 0.25 mg | Drug | Cenicriviroc, Group 1 (Digoxin) |
| CaffeineAlso: Caffine 200 mg | Drug | Cenicriviroc, Group 1 (Caffeine) |
Primary outcome
Pharmacokinetic Assessment of ROS, ATO and Digoxin alone and in the presence of CVC, as measured by maximum plasma concentration (Cmax)
Time frame: Days 1 and 13
Pharmacokinetic Assessment of SIM alone and in the presence of CVC, as measured by maximum plasma concentration (Cmax)
Time frame: Days 1 and 12
Pharmacokinetic Assessment of Caffeine alone and in the presence of CVC, as measured by maximum plasma concentration (Cmax)
Time frame: Days 1 and 13
Pharmacokinetic Assessment of ROS, ATO and Digoxin alone and in the presence of CVC, as measured by minimum plasma concentration (Cmin)
Time frame: Days 1 and 13
Pharmacokinetic Assessment of ROS, ATO and Digoxin alone and in the presence of CVC, as measured by area under the plasma concentration-time curve (AUC)
Time frame: Days 1 and 13
Pharmacokinetic Assessment of SIM alone and in the presence of CVC, as measured by minimum plasma concentration (Cmin)
Time frame: Days 1 and 12
Pharmacokinetic Assessment of SIM alone and in the presence of CVC, as measured by area under the plasma concentration-time curve (AUC)
Time frame: Days 1 and 12
Pharmacokinetic Assessment of Caffeine alone and in the presence of CVC, as measured by minimum plasma concentration (Cmin)
Time frame: Days 1 and 13
Pharmacokinetic Assessment of Caffeine alone and in the presence of CVC, as measured by area under the plasma concentration-time curve (AUC)
Time frame: Days 1 and 13
5 secondary outcomes
Evaluation of Adverse Events
Time frame: 23 days
Changes from Baseline in Clinical Laboratory Tests
Time frame: Baseline and 23 days
Changes from Baseline in 12-lead ECGs
Time frame: Baseline and 23 days
Changes from Baseline in Vital Signs
Time frame: Baseline and 23 days
Changes from Baseline in Physical Examinations
Time frame: Baseline and 23 days
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 24 Nov 2017.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Millie Gottwald, PharmD study director
Tobira Therapeutics, 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 Rosuvastatin, Atorvastatin and Simvastatin in people with Healthy, 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 4 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 24 Nov 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?
Pharmacokinetic Assessment of ROS, ATO and Digoxin alone and in the presence of CVC, as measured by maximum plasma concentration (Cmax) (time frame: Days 1 and 13). The study lists 9 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 24 Nov 2017.