NCT01485146

Brief Summary

This Phase 1, double-blind (sponsor open), placebo controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 in healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

October 25, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 5, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2012

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

3 months

First QC Date

October 25, 2011

Last Update Submit

March 26, 2019

Conditions

Safety Evaluation of Escalating Doses

Outcome Measures

Primary Outcomes (1)

  • Measuring subject safety by collecting and evaluating vital signs, adverse events, and laboratory measures.

    14 days

Secondary Outcomes (1)

  • Measuring the level of ETC-1002 and its metabolite ESP15228 in the blood.

    14 days

Study Arms (3)

Cohort 1

EXPERIMENTAL

8 Healthy Subjects in Phase I Unit

Drug: ETC-1002

Cohort 2

EXPERIMENTAL

8 Healthy Subjects in Phase I Unit

Drug: ETC-1002

Cohort 3

EXPERIMENTAL

8 Healthy Subjects in Phase I Unit

Drug: ETC-1002

Interventions

ETC-1002DRUG

escalating doses

Cohort 1Cohort 2Cohort 3

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and female subjects of non-child bearing potential as determined by medical history, physical exam and vial sign measurements
  • Body Mass Index of 18-32 kg/m2 inclusive with body weight \>50 kg

You may not qualify if:

  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>1.2 x Upper Limit of Normal(ULN), serum creatinine \>ULN, Hemoglobin \<12.0 g/dL
  • Clinically significant disease that requires a physician's care and/or would interfere with study evaluations
  • History of drug or alcohol abuse, consumption of alcohol within 48 hours prior to randomization, or a positive test for alcohol or drugs with a high potential for abuse prior to randomization
  • Use of any prescription or nonprescription drugs, vitamins, or dietary supplements within 14 days prior to randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jasper Clinic, Inc.

Kalamazoo, Michigan, 49007, United States

Location

MeSH Terms

Interventions

8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid

Study Officials

  • Narendra Lalwani, PhD

    Esperion Therapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2011

First Posted

December 5, 2011

Study Start

October 25, 2011

Primary Completion

January 25, 2012

Study Completion

January 25, 2012

Last Updated

March 28, 2019

Record last verified: 2019-03

Locations

US(1)