A Study of IMR-687 in Healthy Adult Volunteers

Sickle Cell Disease Clinical Trial

Official title:

A Phase 1a Study of IMR-687 in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02998450
• Other study ID #: IMR-SCD-101
• Status: Completed
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Hemoglobin SC Disease
• Sickle Beta 0 Thalassemia
• Sickle Cell Disease
• Sickle-Cell; Hb-SC
• Thalassemia

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