Clinical trial NCT02998450: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sickle Cell Disease
Sickle-Cell; Hb-SC
Sickle Beta 0 Thalassemia
Keywords: Sickle Cell Disease
Sickle Beta 0 Thalassemia
Lead sponsor: Cardurion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
name: Imara, Inc.
First posted: 2016-12-20
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of participants with treatment emergent adverse events and serious adverse events
timeFrame: 5 Days
measure: Number of participants with clinically significant changes from baseline in vital signs
timeFrame: Baseline to Day 5
measure: Number of participants with clinically significant changes from baseline in physical examination
timeFrame: Baseline to Day 5
measure: Number of participants with clinically significant changes from baseline in hematology, chemistry, coagulation and urinalysis laboratory values
timeFrame: Baseline to Day 5
measure: Number of participants with clinically significant changes from baseline in 12-lead ECG parameters
timeFrame: Baseline to Day 2
measure: Use of concomitant medications and therapies, medication type and frequency
timeFrame: 5 Days
Secondary outcomes:
measure: Pharmacokinetics (PK) of IMR-687
timeFrame: 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
measure: Pharmacokinetics (PK) of IMR-687
timeFrame: 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
measure: Pharmacokinetics (PK) of IMR-687
timeFrame: 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
measure: Pharmacokinetics (PK) of IMR-687
timeFrame: 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
measure: Pharmacokinetics (PK) of IMR-687
timeFrame: 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
measure: Pharmacokinetics (PK) of IMR-687
timeFrame: 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
measure: The change from baseline in QTcF interval.
timeFrame: 2 Days
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Quintiles
state: Kansas
Study officials:
affiliation: Cardurion Pharmaceuticals
name: Regulatory Operations
role: STUDY_DIRECTOR
References: