Back to resultsA Study of IMR-687 in Healthy Adult Volunteers
Primary Purpose
Sickle Cell Disease, Sickle-Cell; Hb-SC, Sickle Beta 0 Thalassemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IMR-687
Placebo Oral Capsule
Sponsored by
About this trial
This is an interventional treatment trial for Sickle Cell Disease focused on measuring Sickle Cell Disease, Sickle Beta 0 Thalassemia
Eligibility Criteria
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.
Sites / Locations
- Quintiles
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 5
Cohort 6
Arm 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.
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.
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Number of participants with treatment emergent adverse events and serious adverse events
Number of participants with clinically significant changes from baseline in vital signs
Vital signs include blood pressure, heart rate, pulse rate, and oral temperature
Number of participants with clinically significant changes from baseline in physical examination
Number of participants with clinically significant changes from baseline in hematology, chemistry, coagulation and urinalysis laboratory values
Number of participants with clinically significant changes from baseline in 12-lead ECG parameters
Use of concomitant medications and therapies, medication type and frequency
Secondary Outcome Measures
Pharmacokinetics (PK) of IMR-687
Maximum Observed Plasma Concentration (Cmax) of IMR-687
Pharmacokinetics (PK) of IMR-687
Area under the curve (AUC) ( 0 to 24 h) of IMR-687
Pharmacokinetics (PK) of IMR-687
AUC from time 0 to the last measurable time point (AUClast) of IMR-687
Pharmacokinetics (PK) of IMR-687
AUC extrapolated to infinity (AUC0 ∞) of IMR-687
Pharmacokinetics (PK) of IMR-687
Time to maximum concentration (tmax) of IMR-687
Pharmacokinetics (PK) of IMR-687
Apparent terminal half-life (t½) of IMR-687
The change from baseline in QTcF interval.
Full Information
NCT ID
NCT02998450
First Posted
December 6, 2016
Last Updated
March 6, 2023
Sponsor
Imara, Inc.
Collaborators
Quintiles, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02998450
Brief Title
A Study of IMR-687 in Healthy Adult Volunteers
Official Title
A Phase 1a Study of IMR-687 in Healthy Adult Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 18, 2016 (Actual)
Primary Completion Date
July 8, 2017 (Actual)
Study Completion Date
July 8, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imara, Inc.
Collaborators
Quintiles, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease, Sickle-Cell; Hb-SC, Sickle Beta 0 Thalassemia
Keywords
Sickle Cell Disease, Sickle Beta 0 Thalassemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm 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.
Arm Title
Cohort 2
Arm Type
Experimental
Arm 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.
Arm Title
Cohort 3
Arm Type
Experimental
Arm 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.
Arm Title
Cohort 4
Arm Type
Experimental
Arm 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.
Arm Title
Cohort 5
Arm Type
Experimental
Arm 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.
Arm Title
Cohort 6
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
IMR-687
Intervention Description
1 of 6 possible single doses administered orally following overnight fast
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Capsule
Other Intervention Name(s)
Microcrystalline cellulose
Intervention Description
Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.
Primary Outcome Measure Information:
Title
Number of participants with treatment emergent adverse events and serious adverse events
Time Frame
5 Days
Title
Number of participants with clinically significant changes from baseline in vital signs
Description
Vital signs include blood pressure, heart rate, pulse rate, and oral temperature
Time Frame
Baseline to Day 5
Title
Number of participants with clinically significant changes from baseline in physical examination
Time Frame
Baseline to Day 5
Title
Number of participants with clinically significant changes from baseline in hematology, chemistry, coagulation and urinalysis laboratory values
Time Frame
Baseline to Day 5
Title
Number of participants with clinically significant changes from baseline in 12-lead ECG parameters
Time Frame
Baseline to Day 2
Title
Use of concomitant medications and therapies, medication type and frequency
Time Frame
5 Days
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK) of IMR-687
Description
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
Title
Pharmacokinetics (PK) of IMR-687
Description
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
Title
Pharmacokinetics (PK) of IMR-687
Description
AUC from time 0 to the last measurable time point (AUClast) 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
Title
Pharmacokinetics (PK) of IMR-687
Description
AUC extrapolated to infinity (AUC0 ∞) 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
Title
Pharmacokinetics (PK) of IMR-687
Description
Time to maximum concentration (tmax) 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
Title
Pharmacokinetics (PK) of IMR-687
Description
Apparent terminal half-life (t½) 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
Title
The change from baseline in QTcF interval.
Time Frame
2 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Regulatory Operations
Organizational Affiliation
Cardurion Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Quintiles
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Study of IMR-687 in Healthy Adult Volunteers
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