HypercholesterolemiaPhase 1NCT02587364
Pharmacokinetics and Pharmacodynamics Study of Gemcabene in Healthy Volunteers
A Phase 1 study testing Gemcabene 50 mg, Gemcabene 150 mg and Gemcabene 450 mg in people with Hypercholesterolemia, run by NeuroBo Pharmaceuticals Inc..
Trial summary
The purpose of this study is to evaluate the multiple-dose pharmacokinetic characteristics and pharmacologic activity of gemcabene. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Gemcabene 50 mg, Gemcabene 150 mg and Gemcabene 450 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 1999to Sep 1999
- 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
- Good health as determined by medical history, physical examination, electrocardiogram (ECG), vital signs, and laboratory assessments
- Body weight: 60-100 kg (desirable)
Who cannot join
- Use of any medication not considered acceptable by the clinical investigators during the 14-day period before the start of the study (Day 1) ;
- Donation of a unit of blood or participation in a study of investigational or marketed drugs during the 30-day period before the start of the study (Day 1);
- If female, of childbearing potential or lactating;
- History of significant reaction to any fibrate lipid-lowering agent; and
- Significant urine collection of any drug which could interfere with the study
About this study
Official title: An Oral, Rising, Multiple-Dose Tolerance, Pharmacokinetic and Pharmacodynamic Study of Gemcabene Capsules in Healthy Volunteers
The purpose of this study is to evaluate the multiple-dose pharmacokinetic characteristics and pharmacologic activity of gemcabene.
- Conditions
- Hypercholesterolemia
- Being tested
- Gemcabene 50 mg, Gemcabene 150 mg, Gemcabene 450 mg, Gemcabene 750/600 mg, Gemcabene 900 mg
- 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 50 mgDrug
Gemcabene 50 mg once daily (QD)
Gemcabene 150 mgDrug
Gemcabene 150 mg once daily (QD)
Gemcabene 450 mgDrug
Gemcabene 450 mg once daily (QD)
Gemcabene 750/600 mgDrug
Gemcabene 750/600 mg once daily (QD)
Gemcabene 900 mgDrug
Gemcabene 900 mg once daily (QD)
PlaceboDrug
Placebo once daily (QD)
| Study group | Role | What they receive |
|---|---|---|
| Gemcabene 50 mg | Experimental | Gemcabene 50 mg Receives: Drug: Gemcabene 50 mg |
| Gemcabene 150 mg | Experimental | Gemcabene 150 mg Receives: Drug: Gemcabene 150 mg |
| Gemcabene 450 mg | Experimental | Gemcabene 450 mg Receives: Drug: Gemcabene 450 mg |
| Gemcabene 750/600 mg | Experimental | Gemcabene 750/600 mg Receives: Drug: Gemcabene 750/600 mg |
| Gemcabene 900 mg | Experimental | Gemcabene 900 mg Receives: Drug: Gemcabene 900 mg |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
Cmax
Measured: 29 days
Pharmacokinetcis
Area Under the Curve (AUC)
Measured: 29 days
Secondary outcomes (4)
Plasma lipid levels - percent change from baseline at Day 29
percent change from baseline for LDL-C, apolipoprotein B (apoB), total cholesterol (TC), triglyceride (TG), very low density lipoprotein (VLDL-C), high density lipoprotein (HDL-C)
Measured: 29 days
Adverse Events
Measured: 29 days
ECG
Clinically Significant Changes
Measured: 29 days
Clinical Laboratory - hematology, chemistry
Clinical Laboratory Abnormalities
Measured: 29 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 startApr 1999
- Primary completionSep 1999
- Study completionSep 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 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
- NCT02587364
- Sponsor's protocol ID
- 1027-003
- 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
- An Oral, Rising, Multiple-Dose Tolerance, Pharmacokinetic and Pharmacodynamic Study of Gemcabene Capsules in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02587364
- Acronym / sponsor ID
- 1027-003
- Conditions
- Hypercholesterolemia
- Keywords
- Pharmacokinetics, Lipid Regulator
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- NeuroBo Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 1999
- Primary completion
- Sep 1999 (actual)
- Study completion
- Sep 1999 (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 evaluate the multiple-dose pharmacokinetic characteristics and pharmacologic activity of gemcabene.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Gemcabene 50 mg | Experimental | Drug: Gemcabene 50 mgGemcabene 50 mg |
| Gemcabene 150 mg | Experimental | Drug: Gemcabene 150 mgGemcabene 150 mg |
| Gemcabene 450 mg | Experimental | Drug: Gemcabene 450 mgGemcabene 450 mg |
| Gemcabene 750/600 mg | Experimental | Drug: Gemcabene 750/600 mgGemcabene 750/600 mg |
| Gemcabene 900 mg | Experimental | Drug: Gemcabene 900 mgGemcabene 900 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Good health as determined by medical history, physical examination, electrocardiogram (ECG), vital signs, and laboratory assessments
- Body weight: 60-100 kg (desirable)
Key exclusion criteria (5 listed)
- Use of any medication not considered acceptable by the clinical investigators during the 14-day period before the start of the study (Day 1) ;
- Donation of a unit of blood or participation in a study of investigational or marketed drugs during the 30-day period before the start of the study (Day 1);
- If female, of childbearing potential or lactating;
- History of significant reaction to any fibrate lipid-lowering agent; and
- Significant urine collection of any drug which could interfere with the study
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 50 mgGemcabene 50 mg once daily (QD) | Drug | Gemcabene 50 mg |
| Gemcabene 150 mgGemcabene 150 mg once daily (QD) | Drug | Gemcabene 150 mg |
| Gemcabene 450 mgGemcabene 450 mg once daily (QD) | Drug | Gemcabene 450 mg |
| Gemcabene 750/600 mgGemcabene 750/600 mg once daily (QD) | Drug | Gemcabene 750/600 mg |
| Gemcabene 900 mgGemcabene 900 mg once daily (QD) | Drug | Gemcabene 900 mg |
| PlaceboPlacebo once daily (QD) | Drug | Placebo |
Primary outcome
Pharmacokinetics
Time frame: 29 days
Cmax
Pharmacokinetcis
Time frame: 29 days
Area Under the Curve (AUC)
4 secondary outcomes
Plasma lipid levels - percent change from baseline at Day 29
Time frame: 29 days
Adverse Events
Time frame: 29 days
ECG
Time frame: 29 days
Clinical Laboratory - hematology, chemistry
Time frame: 29 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 50 mg, Gemcabene 150 mg and Gemcabene 450 mg in people with Hypercholesterolemia, 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 2 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 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. Some participants in this study may receive a placebo. 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: 29 days). 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.