A Study of IMR-687 in Healthy Adult Volunteers

May 13, 2025 updated by: Cardurion Pharmaceuticals, Inc.

A Phase 1a Study of IMR-687 in Healthy Adult Volunteers

The purpose of this Phase 1a, first in human, randomized, double-blind, placebo-controlled study is to evaluate the safety, tolerability, PK and PD profile of the orally administered IMR-687 in healthy adult subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Quintiles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Be healthy as judged by the Investigator on the basis of pre-study tests performed at Screening, with healthy body mass index (BMI), healthy body weight, and laboratory results within normal laboratory reference range or determined not to be clinically significant by the Investigator; and be free from drugs of abuse.

Exclusion Criteria:

  • Females who are pregnant, trying to become pregnant, or breastfeeding; and males with female partners who are trying to conceive.
  • Asthmatics or other individuals who use or may use albuterol rescue inhalers or nebulizers.
  • A significant history of cardiovascular disease.
  • On ECG, a QTcF >450 ms or the presence of clinically significant abnormalities as determined by the Investigator.
  • Elevated blood pressure.
  • Use within 30 days prior to Day 1 of any inhibitors or substrates of targets of IMR-687.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1

4 Subjects will receive a single low dose of IMR-687, administered orally following an overnight fast.

2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.
Drug: IMR-687
1 of 6 possible single doses administered orally following overnight fast
Drug: Placebo Oral Capsule
Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.
Other Names:
  • Microcrystalline cellulose
Experimental: Cohort 2

4 Subjects will receive a single low-mid dose of IMR-687, administered orally following an overnight fast.

2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.
Drug: IMR-687
1 of 6 possible single doses administered orally following overnight fast
Drug: Placebo Oral Capsule
Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.
Other Names:
  • Microcrystalline cellulose
Experimental: Cohort 3

4 Subjects will receive a single mid-low dose of IMR-687, administered orally following an overnight fast.

2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.
Drug: IMR-687
1 of 6 possible single doses administered orally following overnight fast
Drug: Placebo Oral Capsule
Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.
Other Names:
  • Microcrystalline cellulose
Experimental: Cohort 4

4 Subjects will receive a single mid dose of IMR-687, administered orally following an overnight fast.

2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.
Drug: IMR-687
1 of 6 possible single doses administered orally following overnight fast
Drug: Placebo Oral Capsule
Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.
Other Names:
  • Microcrystalline cellulose
Experimental: Cohort 5

4 Subjects will receive a single mid-high dose of IMR-687, administered orally following an overnight fast.

2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.
Drug: IMR-687
1 of 6 possible single doses administered orally following overnight fast
Drug: Placebo Oral Capsule
Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.
Other Names:
  • Microcrystalline cellulose
Experimental: Cohort 6

4 Subjects will receive a single high dose of IMR-687, administered orally following an overnight fast.

2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.
Drug: IMR-687
1 of 6 possible single doses administered orally following overnight fast
Drug: Placebo Oral Capsule
Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.
Other Names:
  • Microcrystalline cellulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment emergent adverse events and serious adverse events
Time Frame: 5 Days
5 Days
Number of participants with clinically significant changes from baseline in vital signs
Time Frame: Baseline to Day 5
Vital signs include blood pressure, heart rate, pulse rate, and oral temperature
Baseline to Day 5
Number of participants with clinically significant changes from baseline in physical examination
Time Frame: Baseline to Day 5
Baseline to Day 5
Number of participants with clinically significant changes from baseline in hematology, chemistry, coagulation and urinalysis laboratory values
Time Frame: Baseline to Day 5
Baseline to Day 5
Number of participants with clinically significant changes from baseline in 12-lead ECG parameters
Time Frame: Baseline to Day 2
Baseline to Day 2
Use of concomitant medications and therapies, medication type and frequency
Time Frame: 5 Days
5 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK) of IMR-687
Time Frame: Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose
Maximum Observed Plasma Concentration (Cmax) of IMR-687
Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose
Pharmacokinetics (PK) of IMR-687
Time Frame: Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose
Area under the curve (AUC) ( 0 to 24 h) of IMR-687
Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose
Pharmacokinetics (PK) of IMR-687
Time Frame: Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose
AUC from time 0 to the last measurable time point (AUClast) of IMR-687
Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose
Pharmacokinetics (PK) of IMR-687
Time Frame: Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose
AUC extrapolated to infinity (AUC0 ∞) of IMR-687
Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose
Pharmacokinetics (PK) of IMR-687
Time Frame: Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose
Time to maximum concentration (tmax) of IMR-687
Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose
Pharmacokinetics (PK) of IMR-687
Time Frame: Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose
Apparent terminal half-life (t½) of IMR-687
Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose
The change from baseline in QTcF interval.
Time Frame: 2 Days
2 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardurion Pharmaceuticals, Inc.

Collaborators

Quintiles, Inc.
Imara, Inc.

Investigators

  • Study Director: Regulatory Operations, Cardurion Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2016

Primary Completion (Actual)

July 8, 2017

Study Completion (Actual)

July 8, 2017

Study Registration Dates

First Submitted

December 6, 2016

First Submitted That Met QC Criteria

December 15, 2016

First Posted (Estimated)

December 20, 2016

Study Record Updates

Last Update Posted (Actual)

May 15, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMR-SCD-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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