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A Study of IMR-687 in Healthy Adult Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02998450
Recruitment Status : Completed
First Posted : December 20, 2016
Last Update Posted : March 8, 2023
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
Imara, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Sickle-Cell; Hb-SC Sickle Beta 0 Thalassemia Drug: IMR-687 Drug: Placebo Oral Capsule Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1a Study of IMR-687 in Healthy Adult Volunteers
Actual Study Start Date : October 18, 2016
Actual Primary Completion Date : July 8, 2017
Actual Study Completion Date : July 8, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1

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.

 Drug: IMR-687
1 of 6 possible single doses administered orally following overnight fast

Drug: Placebo Oral Capsule
Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.
Other Name: Microcrystalline cellulose
Experimental: Cohort 2

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.

 Drug: IMR-687
1 of 6 possible single doses administered orally following overnight fast

Drug: Placebo Oral Capsule
Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.
Other Name: Microcrystalline cellulose
Experimental: Cohort 3

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.

 Drug: IMR-687
1 of 6 possible single doses administered orally following overnight fast

Drug: Placebo Oral Capsule
Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.
Other Name: Microcrystalline cellulose
Experimental: Cohort 4

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.

 Drug: IMR-687
1 of 6 possible single doses administered orally following overnight fast

Drug: Placebo Oral Capsule
Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.
Other Name: Microcrystalline cellulose
Experimental: Cohort 5

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.

 Drug: IMR-687
1 of 6 possible single doses administered orally following overnight fast

Drug: Placebo Oral Capsule
Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.
Other Name: Microcrystalline cellulose
Experimental: Cohort 6

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.

 Drug: IMR-687
1 of 6 possible single doses administered orally following overnight fast

Drug: Placebo Oral Capsule
Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.
Other Name: Microcrystalline cellulose


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with treatment emergent adverse events and serious adverse events [ Time Frame: 5 Days ]
  2. Number of participants with clinically significant changes from baseline in vital signs [ Time Frame: Baseline to Day 5 ]
    Vital signs include blood pressure, heart rate, pulse rate, and oral temperature

  3. Number of participants with clinically significant changes from baseline in physical examination [ Time Frame: Baseline to Day 5 ]
  4. Number of participants with clinically significant changes from baseline in hematology, chemistry, coagulation and urinalysis laboratory values [ Time Frame: Baseline to Day 5 ]
  5. Number of participants with clinically significant changes from baseline in 12-lead ECG parameters [ Time Frame: Baseline to Day 2 ]
  6. Use of concomitant medications and therapies, medication type and frequency [ Time Frame: 5 Days ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK) 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 ]
    Maximum Observed Plasma Concentration (Cmax) of IMR-687

  2. Pharmacokinetics (PK) 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 ]
    Area under the curve (AUC) ( 0 to 24 h) of IMR-687

  3. Pharmacokinetics (PK) 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 ]
    AUC from time 0 to the last measurable time point (AUClast) of IMR-687

  4. Pharmacokinetics (PK) 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 ]
    AUC extrapolated to infinity (AUC0 ∞) of IMR-687

  5. Pharmacokinetics (PK) 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 ]
    Time to maximum concentration (tmax) of IMR-687

  6. Pharmacokinetics (PK) 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 ]
    Apparent terminal half-life (t½) of IMR-687

  7. The change from baseline in QTcF interval. [ Time Frame: 2 Days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998450


Locations
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United States, Kansas
Quintiles
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Imara, Inc.
Quintiles, Inc.
Investigators
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Study Director: Regulatory Operations Cardurion Pharmaceuticals
More Information
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Responsible Party: Imara, Inc.
ClinicalTrials.gov Identifier: NCT02998450    
Other Study ID Numbers: IMR-SCD-101
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: March 8, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Imara, Inc.:
Sickle Cell Disease
Sickle Beta 0 Thalassemia
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Thalassemia
Hemoglobin SC Disease
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn