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Phase 1 Study in Healthy Subjects to Evaluate the Effect of IPI-145 on the Pharmacokinetics of Midazolam (DDI)

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ClinicalTrials.gov Identifier: NCT01925911
Recruitment Status : Completed
First Posted : August 20, 2013
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Verastem, Inc.

Brief Summary:
To evaluate the effect of IPI-145 on the pharmacokinetics of midazolam, a cytochrome P450 3A (CYP3A) substrate; to assess the safety and tolerability of IPI-145 when administered with midazolam in healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: IPI-145 Drug: Midazolam Phase 1

Detailed Description:
  • In Treatment Period 1, subjects will receive a single 2 mg oral dose of midazolam.
  • In Treatment Period 2, on Days 2-6, the same subjects will receive twice daily (BID) oral doses of 25 mg IPI-145; on Day 6, subjects will receive the morning dose of 25 mg IPI-145 concomitantly administered with 2 mg of midazolam.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1, Open-Label, Single-Sequence, 2-Period Study to Evaluate the Effect of IPI-145 on Single-Dose Pharmacokinetics of Midazolam (a CYP3A Substrate) in Healthy Subjects
Study Start Date : August 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: IPI-145
    25 mg BID Oral Capsule
  • Drug: Midazolam
    2 mg midazolam syrup


Primary Outcome Measures :
  1. Pharmacokinetic parameters (AUC) of midazolam and 1-hydroxy-midazolam [ Time Frame: Over 24 hours ]
  2. Pharmacokinetic parameters (Cmax) of midazolam and 1-hydroxy-midazolam [ Time Frame: Over 24 hours ]
  3. Pharmacokinetic parameters (t1/2) of midazolam and 1-hydroxy-midazolam [ Time Frame: Over 24 hours ]
  4. Plasma concentrations of midazolam and 1-hydroxy-midazolam [ Time Frame: Over 24 hours ]

Secondary Outcome Measures :
  1. Incidence of adverse events following of administration midazolam, IPI-145 and the combination [ Time Frame: 2 weeks ]
    Safety Findings



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men or women of non-childbearing potential between 18-50 years of age
  • Body Mass Index (BMI): 18.0 - 32.0 kg/m2.
  • In good health, determined by no clinically significant findings from clinical evaluations
  • Provided written informed consent prior to any study specific procedures

Exclusion Criteria:

  • Women of childbearing potential
  • Evidence of clinically significant medical conditions
  • History of gastrointestinal disease or surgery that may affect drug absorption
  • Positive or indeterminate tuberculosis-spot test at screening
  • Any active infection at the time of screening or admission
  • Subjects with acute narrow-angle glaucoma

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): NCT01925911


Locations
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United States, Kansas
PRA International
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Verastem, Inc.
Investigators
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Study Chair: Hagop Youssoufian, MD Verastem, Inc.

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Responsible Party: Verastem, Inc.
ClinicalTrials.gov Identifier: NCT01925911     History of Changes
Other Study ID Numbers: IPI-145-10
First Posted: August 20, 2013    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: July 2017
Keywords provided by Verastem, Inc.:
Phase 1
Healthy subjects
DDI
CYP3A
Additional relevant MeSH terms:
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Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action