A Study of IMR-687 in Healthy Adult Volunteers

Cardurion Pharmaceuticals

Status and phase: Completed; Phase 1

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

Treatments: Drug: IMR-687; Drug: Placebo Oral Capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT02998450

IMR-SCD-101

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 6 patient groups

Cohort 1

Experimental group

Description:

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.

Treatment:

Drug: Placebo Oral Capsule

Drug: IMR-687

Cohort 2

Experimental group

Description:

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.

Treatment:

Drug: Placebo Oral Capsule

Drug: IMR-687

Cohort 3

Experimental group

Description:

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.

Treatment:

Drug: Placebo Oral Capsule

Drug: IMR-687

Cohort 4

Experimental group

Description:

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.

Treatment:

Drug: Placebo Oral Capsule

Drug: IMR-687

Cohort 5

Experimental group

Description:

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.

Treatment:

Drug: Placebo Oral Capsule

Drug: IMR-687

Cohort 6

Experimental group

Description:

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.

Treatment:

Drug: Placebo Oral Capsule

Drug: IMR-687