Effect of Gemcabene on the Pharmacokinetics of Atorvastat... | NCT02587416

Studies
Effect of Gemcabene on the Pharmacokinetics of Atorvastatin in Healthy Volunteers

NCT02587416

Sponsor

NeuroBo Pharmaceuticals Inc.

Status

Completed

Last Update Posted

Apr 9, 2020Actual

Enrollment

20Actual

Phase

Phase 1

Conditions

Hypercholesteremia

Interventions

Gemcabene 300 mg
Gemcabene 900 mg
Atorvastatin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2002

Primary Completion Date

Dec 2002Actual

Completion Date

Dec 2002Actual

First Submitted Date

Oct 22, 2015

First Submission Date that Met QC Criteria

Oct 23, 2015

First Posted Date

Oct 27, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2020

Last Update Posted Date

Apr 9, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gemcabene 300 mg	Experimental	Gemcabene 300 mg	Drug: Gemcabene 300 mg Drug: Atorvastatin
Gemcabene 900 mg	Experimental	Gemcabene 900 mg	Drug: Gemcabene 900 mg Drug: Atorvastatin
Atorvastatin 80 mg	Active Comparator	Atorvastatin 80 mg	Drug: Atorvastatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gemcabene 300 mg	Drug	1x300 mg gemcabene tablets orally once daily (QD) for 11 days	Gemcabene 300 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetics	Cmax	Days 5, 16 and 27
Pharmacokinetics	Area Under the Curve (AUC)	Days 5, 16, and 27

Secondary Outcomes

Measure	Description	Time Frame
Adverse Events		27 days
Clinical Laboratory - hematology, chemistry, urinalysis	Clinical Laboratory Abnormalities	27 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

If female, of childbearing potential or lactation
History of significant adverse reaction to any lipid-lowering agent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006937	Hypercholesterolemia

Ancestor Terms

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C111024	gemcabene
D000069059	Atorvastatin

Ancestor Terms

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided