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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02998450
Other study ID # IMR-SCD-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 18, 2016
Est. completion date July 8, 2017

Study information

Verified date March 2023
Source Imara, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date July 8, 2017
Est. primary completion date July 8, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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


Intervention

Drug:
IMR-687
1 of 6 possible single doses administered orally following overnight fast
Placebo Oral Capsule
Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.

Locations

Country Name City State
United States Quintiles Overland Park Kansas

Sponsors (2)

Lead Sponsor Collaborator
Imara, Inc. Quintiles, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with treatment emergent adverse events and serious adverse events 5 Days
Primary 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
Primary Number of participants with clinically significant changes from baseline in physical examination Baseline to Day 5
Primary Number of participants with clinically significant changes from baseline in hematology, chemistry, coagulation and urinalysis laboratory values Baseline to Day 5
Primary Number of participants with clinically significant changes from baseline in 12-lead ECG parameters Baseline to Day 2
Primary Use of concomitant medications and therapies, medication type and frequency 5 Days
Secondary Pharmacokinetics (PK) of IMR-687 Maximum Observed Plasma Concentration (Cmax) 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
Secondary Pharmacokinetics (PK) of IMR-687 Area under the curve (AUC) ( 0 to 24 h) 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
Secondary Pharmacokinetics (PK) of IMR-687 AUC from time 0 to the last measurable time point (AUClast) 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
Secondary Pharmacokinetics (PK) of IMR-687 AUC extrapolated to infinity (AUC0 8) 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
Secondary Pharmacokinetics (PK) of IMR-687 Time to maximum concentration (tmax) 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
Secondary Pharmacokinetics (PK) of IMR-687 Apparent terminal half-life (t½) 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
Secondary The change from baseline in QTcF interval. 2 Days
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