Clinical Trial: A Study of IMR-687 in Healthy Adult Volunteers

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Summary:
Sponsor: Imara, Inc.

Current Primary Outcome:

  • 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Imara, Inc.

Dates:
Date Received: December 6, 2016
Date Started: November 2016
Date Completion: June 2017
Last Updated: December 15, 2016
Last Verified: December 2016