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Completed

NCT Number: NCT02998450

A 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.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobin SC Disease Hemoglobinopathies Sickle Beta 0 Thalassemia Sickle-Cell; Hb-SC

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quintiles

Overland Park, Kansas, 66211, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IMR-687

Drug

1 of 6 possible single doses administered orally following overnight fast

Placebo oral capsule

Drug

Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.

Other names: Microcrystalline cellulose

Primary outcomes

  1. Number of participants with treatment emergent adverse events and serious adverse events

    Time frame: 5 Days

  2. 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

  3. Number of participants with clinically significant changes from baseline in physical examination

    Time frame: Baseline to Day 5

  4. Number of participants with clinically significant changes from baseline in hematology, chemistry, coagulation and urinalysis laboratory values

    Time frame: Baseline to Day 5

  5. Number of participants with clinically significant changes from baseline in 12-lead ECG parameters

    Time frame: Baseline to Day 2

  6. Use of concomitant medications and therapies, medication type and frequency

    Time frame: 5 Days

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. The change from baseline in QTcF interval.

    Time frame: 2 Days

Sponsors and collaborators

Lead sponsor

Cardurion Pharmaceuticals, Inc.

Industry

Collaborators

  • Imara, Inc.
  • Quintiles, Inc.

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 20, 2016
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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