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THE EFFECT OF MULTIPLE DOSES OF PF-06835919 ON THE PHARMACOKINETICS OF A SINGLE ORAL MIDAZOLAM DOSE IN HEALTHY PARTICIPANTS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03916406
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This is a Phase 1, randomized, open label, 2 way crossover drug drug interaction (DDI) study which will evaluate the impact of PF 06835919 on midazolam pharmacokinetics in healthy participants. Participants will be randomized to 1 of 2 treatment sequences as described below. A total of approximately 10 healthy male and/or female participants will be enrolled in this study so that approximately 5 participants will be enrolled into each treatment sequence. In this crossover study, 2 treatments are being assessed.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: PF 06835919 Drug: Midazolam Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A PHASE 1, RANDOMIZED, OPEN LABEL, 2-WAY CROSSOVER STUDY TO EVALUATE THE EFFECT OF REPEATED DOSING OF PF-06835919 ON THE PHARMACOKINETICS OF A SINGLE ORAL DOSE OF MIDAZOLAM IN HEALTHY PARTICIPANTS
Actual Study Start Date : April 18, 2019
Actual Primary Completion Date : June 25, 2019
Actual Study Completion Date : June 25, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sequence 1
midazolam alone followed by combination of PF 06835919 and midazolam
Drug: PF 06835919
300 mg

Drug: Midazolam
7.5 mg

Experimental: Sequence 2
PF 06835919 in combination with midazolam followed by midazolam alone
Drug: PF 06835919
300 mg

Drug: Midazolam
7.5 mg




Primary Outcome Measures :
  1. AUCinf of midazolam following a single oral dose [ Time Frame: Baseline up to 51 days ]
    Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)


Secondary Outcome Measures :
  1. AUClast of midazolam following a single oral dose. [ Time Frame: Baseline up to 51 days ]
    Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

  2. Cmax of midazolam following a single oral dose. [ Time Frame: Baseline up to 51 days ]
    Maximum Observed Plasma Concentration (Cmax)

  3. Incidence of Adverse Events in participants [ Time Frame: Screening up to 79 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiovascular tests.
  • Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed
  • Participants, who according to the product label for midazolam, would be at increased risk if dosed with midazolam (ie, including but not limited to participants with history of myasthenia gravis, chronic obstructive pulmonary disease (COPD), pulmonary insufficiency, glaucoma, concomitant central nervous system (CNS) depressants).
  • History of hypersensitivity to midazolam or any other benzodiazepine

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): NCT03916406


Locations
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Belgium
Brussels Clinical Research Unit
Brussels, Be-bru, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03916406    
Other Study ID Numbers: C1061016
2019-000929-42 ( EudraCT Number )
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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