HypercholesteremiaPhase 1NCT02587416
Effect of Gemcabene on the Pharmacokinetics of Atorvastatin in Healthy Volunteers
A Phase 1 study testing Gemcabene 300 mg, Gemcabene 900 mg and Atorvastatin in people with Hypercholesteremia, run by NeuroBo Pharmaceuticals Inc..
Trial summary
The purpose of this study is to determine the effect of gemcabene on the pharmacokinetics of atorvastatin 80 mg Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesteremia
- What is being tested?
- Gemcabene 300 mg, Gemcabene 900 mg and Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Dec 2002
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and Females
- 18-65 years of age
- Good health as determined by medical history, physical examination, vital signs, ECG, and clinical laboratory measurements;
- Body weight 45 kg or greater, with a body mass index (BMI) ≤ 35 kg/m² (weight [kg]/height[meters]²)
Who cannot join
- If female, of childbearing potential or lactation
- History of significant adverse reaction to any lipid-lowering agent
About this study
Official title: A Study of the Effect of Oral, Multiple-Dose 300 mg and 900 mg Gemcabene (CI-1027) Administration on the Steady-State Pharmacokinetics of Atorvastatin 80 mg
The purpose of this study is to determine the effect of gemcabene on the pharmacokinetics of atorvastatin 80 mg
- Conditions
- Hypercholesteremia
- Being tested
- Gemcabene 300 mg, Gemcabene 900 mg, Atorvastatin
- Keywords
- Pharmacokinetics, Lipid Regulator
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcabene 300 mgDrug
1x300 mg gemcabene tablets orally once daily (QD) for 11 days
Gemcabene 900 mgDrug
3x300 mg Gemcabene tablets orally once daily (QD) for 11 days
AtorvastatinDrug
2x40 mg Atorvastatin tablets orally once daily (QD)
| Study group | Role | What they receive |
|---|---|---|
| Gemcabene 300 mg | Experimental | Gemcabene 300 mg Receives: Drug: Gemcabene 300 mg; Drug: Atorvastatin |
| Gemcabene 900 mg | Experimental | Gemcabene 900 mg Receives: Drug: Gemcabene 900 mg; Drug: Atorvastatin |
| Atorvastatin 80 mg | Active comparator | Atorvastatin 80 mg Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
Cmax
Measured: Days 5, 16 and 27
Pharmacokinetics
Area Under the Curve (AUC)
Measured: Days 5, 16, and 27
Secondary outcomes (3)
Adverse Events
Measured: 27 days
Clinical Laboratory - hematology, chemistry, urinalysis
Clinical Laboratory Abnormalities
Measured: 27 days
ECG
Clinically Significant Changes
Measured: 27 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startNov 2002
- Primary completionDec 2002
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesteremiaStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroBo Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587416
- Sponsor's protocol ID
- A4141002
- Status last verified
- Apr 2020
- First submitted
- 22 Oct 2015
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effect of Oral, Multiple-Dose 300 mg and 900 mg Gemcabene (CI-1027) Administration on the Steady-State Pharmacokinetics of Atorvastatin 80 mg
- ClinicalTrials.gov ID
- NCT02587416
- Acronym / sponsor ID
- A4141002
- Conditions
- Hypercholesteremia
- Keywords
- Pharmacokinetics, Lipid Regulator
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NeuroBo Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Dec 2002 (actual)
- Study completion
- Dec 2002 (actual)
- First posted
- 27 Oct 2015 (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 determine the effect of gemcabene on the pharmacokinetics of atorvastatin 80 mg
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gemcabene 300 mg | Experimental | Drug: Gemcabene 300 mg, Drug: AtorvastatinGemcabene 300 mg |
| Gemcabene 900 mg | Experimental | Drug: Gemcabene 900 mg, Drug: AtorvastatinGemcabene 900 mg |
| Atorvastatin 80 mg | Active comparator | Drug: AtorvastatinAtorvastatin 80 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and Females
- 18-65 years of age
- Good health as determined by medical history, physical examination, vital signs, ECG, and clinical laboratory measurements;
- Body weight 45 kg or greater, with a body mass index (BMI) ≤ 35 kg/m² (weight [kg]/height[meters]²)
Key exclusion criteria (2 listed)
- If female, of childbearing potential or lactation
- History of significant adverse reaction to any lipid-lowering agent
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 |
|---|---|---|
| Gemcabene 300 mg1x300 mg gemcabene tablets orally once daily (QD) for 11 days | Drug | Gemcabene 300 mg |
| Gemcabene 900 mg3x300 mg Gemcabene tablets orally once daily (QD) for 11 days | Drug | Gemcabene 900 mg |
| Atorvastatin2x40 mg Atorvastatin tablets orally once daily (QD) | Drug | Atorvastatin 80 mg, Gemcabene 300 mg, Gemcabene 900 mg |
Primary outcome
Pharmacokinetics
Time frame: Days 5, 16 and 27
Cmax
Pharmacokinetics
Time frame: Days 5, 16, and 27
Area Under the Curve (AUC)
3 secondary outcomes
Adverse Events
Time frame: 27 days
Clinical Laboratory - hematology, chemistry, urinalysis
Time frame: 27 days
ECG
Time frame: 27 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 9 Apr 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gemcabene 300 mg, Gemcabene 900 mg and Atorvastatin in people with Hypercholesteremia, run by NeuroBo Pharmaceuticals Inc..
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 2 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 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Pharmacokinetics (time frame: Days 5, 16 and 27). 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 9 Apr 2020.