A Study of IMR-687 in Healthy Adult Volunteers
Phase 1
Completed
- Conditions
- Sickle-Cell; Hb-SCSickle Cell DiseaseSickle Beta 0 Thalassemia
- Interventions
- Drug: Placebo Oral Capsule
- Registration Number
- NCT02998450
- Lead Sponsor
- Cardurion Pharmaceuticals, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 IMR-687 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. Cohort 1 Placebo Oral Capsule 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. Cohort 2 Placebo Oral Capsule 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. Cohort 3 IMR-687 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. Cohort 3 Placebo Oral Capsule 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. Cohort 4 Placebo Oral Capsule 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. Cohort 5 Placebo Oral Capsule 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. Cohort 6 Placebo Oral Capsule 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. Cohort 4 IMR-687 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. Cohort 5 IMR-687 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. Cohort 6 IMR-687 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. Cohort 2 IMR-687 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.
- Primary Outcome Measures
Name Time Method 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 Baseline to Day 5 Vital signs include blood pressure, heart rate, pulse rate, and oral temperature
Number of participants with clinically significant changes from baseline in 12-lead ECG parameters Baseline to Day 2 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 Use of concomitant medications and therapies, medication type and frequency 5 Days
- Secondary Outcome Measures
Name Time Method The change from baseline in QTcF interval. 2 Days 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 Apparent terminal half-life (t½) of IMR-687
Trial Locations
- Locations (1)
Quintiles
🇺🇸Overland Park, Kansas, United States