A Study of IMR-687 in Healthy Adult Volunteers

• ClinicalTrials.gov Identifier: NCT02998450
• Recruitment Status: Completed
• First Posted: December 20, 2016
• Last Update Posted: March 8, 2023
• Sponsor: Imara, Inc.
• Collaborator: Quintiles, Inc.
• Information provided by (Responsible Party): Imara, Inc.

Tracking Information

• First Submitted Date: December 6, 2016
• First Posted Date: December 20, 2016
• Last Update Posted Date: March 8, 2023
• Actual Study Start Date: October 18, 2016
• Actual Primary Completion Date: July 8, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 15, 2016)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 15, 2016)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of IMR-687 in Healthy Adult Volunteers
• Official Title: A Phase 1a Study of IMR-687 in Healthy Adult Volunteers
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Sickle Cell Disease
• Sickle-Cell; Hb-SC
• Sickle Beta 0 Thalassemia

Intervention

• 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

Study Arms

• 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.

  Interventions:

  • Drug: IMR-687
  • Drug: Placebo Oral Capsule
• 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.

  Interventions:

  • Drug: IMR-687
  • Drug: Placebo Oral Capsule
• 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.

  Interventions:

  • Drug: IMR-687
  • Drug: Placebo Oral Capsule
• 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.

  Interventions:

  • Drug: IMR-687
  • Drug: Placebo Oral Capsule
• 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.

  Interventions:

  • Drug: IMR-687
  • Drug: Placebo Oral Capsule
• 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.

  Interventions:

  • Drug: IMR-687
  • Drug: Placebo Oral Capsule

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 31, 2018): 66
• Original Estimated Enrollment (submitted: December 15, 2016): 36
• Actual Study Completion Date: July 8, 2017
• Actual Primary Completion Date: July 8, 2017 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02998450
• Other Study ID Numbers: IMR-SCD-101
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Imara, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Imara, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Quintiles, Inc.

Investigators

• Study Director: Regulatory Operations; Cardurion Pharmaceuticals

• PRS Account: Imara, Inc.
• Verification Date: March 2023