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Trial record 1 of 1 for:    IMR-687
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A Study of IMR-687 in Healthy Adult Volunteers

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by Imara, Inc.
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
Imara, Inc.
ClinicalTrials.gov Identifier:
NCT02998450
First received: December 6, 2016
Last updated: December 15, 2016
Last verified: December 2016
  Purpose
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 Intervention Phase
Sickle Cell Disease
Sickle-Cell; Hb-SC
Sickle Beta 0 Thalassemia
Drug: IMR-687
Drug: Placebo Oral Capsule
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Imara, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 36
Study Start Date: November 2016
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02998450

Contacts
Contact: James McArthur, PhD 1-617-231-6009 jmcarthur@imaratx.com

Locations
United States, Kansas
Quintiles Recruiting
Overland Park, Kansas, United States, 66211
Contact: 24-Hour Emergency Contact    913-940-8736      
Principal Investigator: Scott Rasmussen, MD         
Sponsors and Collaborators
Imara, Inc.
Quintiles, Inc.
Investigators
Principal Investigator: Scott Rasmussen, MD Quintiles, Inc.
  More Information

Responsible Party: Imara, Inc.
ClinicalTrials.gov Identifier: NCT02998450     History of Changes
Other Study ID Numbers: IMR-SCD-101
Study First Received: December 6, 2016
Last Updated: December 15, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Imara, Inc.:
Sickle Cell Disease
Sickle Beta 0 Thalassemia

Additional relevant MeSH terms:
Anemia, Sickle Cell
Thalassemia
Hemoglobin SC Disease
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 24, 2017