A Study of IMR-687 in Healthy Adult Volunteers

Cardurion Pharmaceuticals, Inc.66 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

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

Interventions

IMR-687DRUG

1 of 6 possible single doses administered orally following overnight fast

Placebo Oral CapsuleDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Quintiles

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: Baseline to Day 5

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

Time frame: 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

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

Time frame: Baseline to Day 2

Use of concomitant medications and therapies, medication type and frequency

Time frame: 5 Days

Secondary Outcomes

Pharmacokinetics (PK) of IMR-687

Maximum Observed Plasma Concentration (Cmax) 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

Pharmacokinetics (PK) of IMR-687

Area under the curve (AUC) ( 0 to 24 h) 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

Pharmacokinetics (PK) of IMR-687

Data from ClinicalTrials.gov

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