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Completed

NCT Number: NCT03762928

ESTIMATION OF THE EFFECT OF MULTIPLE DOSE PF-06651600 ON THE PHARMACOKINETICS OF SINGLE DOSE MIDAZOLAM AND EFAVIRENZ

The current study will estimate any inhibitive or inductive effect of PF-06651600 on the pharmacokinetics of midazolam and efavirenz.

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Key information

Conditions

Healthy Subjects

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male and female participants who are healthy Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease
  • Any condition possibly affecting drug absorption
  • Known immunodeficiency.
  • Infection with hepatitis B or hepatitis C viruses
  • acute or chronic infections or infection history judged to be clinically significant by the investigator
  • History of any lymphoproliferative disorder
  • known present or a history of malignancy other than a successfully treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
  • live (attenuated) vaccines within 6 weeks prior to the first dose of investigational product.

Treatment and study plan

PF-06651600

Drug

200 milligram (mg) PF-06651600 once daily (QD) orally for 11 days

midazolam

Drug

single administration of midazolam 2 mg oral solution

Efavirenz

Drug

single administration of efavirenz 50 mg capsule

Primary outcomes

  1. single dose Area under the curve at last quantifiable infinity time of midazolam

    Time frame: Hour 0, 0,5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose

  2. Single dose Area under the Curve from time 0 to 72 hours post-dose of efavirenz

    Time frame: hour 0, 0,5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose

Secondary outcomes

  1. number of subjects with significant change from baseline in vital signs

    Time frame: hour 0 on study days 1, 4, 10 and 13 post-dose

  2. number of subjects with significant change from baseline in laboratory safety tests results

    Time frame: study days -1, 4, 13 post-dose

  3. number of subjects with treatment emergent adverse events (TEAE)

    Time frame: Baseline up to 35 days post dose

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 1, RANDOMIZED, OPEN LABEL, 2-WAY CROSSOVER STUDY TO ESTIMATE THE EFFECT OF MULTIPLE DOSE PF-06651600 ON THE PHARMACOKINETICS OF SINGLE DOSE MIDAZOLAM AND EFAVIRENZ IN HEALTHY PARTICIPANTS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 4, 2018
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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