A Study of IMR-687 in Healthy Adult Volunteers

NCT02998450 | Completed Phase 1

• 1 other identifier: IMR-SCD-101
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sickle Cell Disease; Sickle-Cell; Hb-SC; Sickle Beta 0 Thalassemia

Keywords

Sickle Cell Disease; Sickle Beta 0 Thalassemia

Outcome Measures

Primary Outcomes (6)

• Number of participants with treatment emergent adverse events and serious adverse events

  5 Days

• Number of participants with clinically significant changes from baseline in vital signs

  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

  Baseline to Day 5

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

  Baseline to Day 5

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

  Baseline to Day 2

• Use of concomitant medications and therapies, medication type and frequency

  5 Days

Secondary Outcomes (7)

• Pharmacokinetics (PK) 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

  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

  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

  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

  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

Study Arms (6)

Cohort 1

EXPERIMENTAL

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; Drug: Placebo Oral Capsule

Cohort 2

EXPERIMENTAL

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; Drug: Placebo Oral Capsule

Cohort 3

EXPERIMENTAL

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; Drug: Placebo Oral Capsule

Cohort 4

EXPERIMENTAL

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; Drug: Placebo Oral Capsule

Cohort 5

EXPERIMENTAL

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; Drug: Placebo Oral Capsule

Cohort 6

EXPERIMENTAL

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; Drug: Placebo Oral Capsule

Interventions

IMR-687 DRUG

1 of 6 possible single doses administered orally following overnight fast

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6

Placebo Oral Capsule DRUG

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

Also known as: Microcrystalline cellulose

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardurion Pharmaceuticals, Inc.: lead
• Quintiles, Inc.: collaborator
• Imara, Inc.: collaborator

Study Sites (1)

Quintiles

Overland Park, Kansas, 66211, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Hemoglobin SC Disease

Interventions

microcrystalline cellulose

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Regulatory Operations

  Cardurion Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 20, 2016
• Study Start: October 18, 2016
• Primary Completion: July 8, 2017
• Study Completion: July 8, 2017
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)