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Completed

NCT Number: NCT02217787

Food Effect Study for PF-06372865

This study has been designed to investigate the effect of high fat food on the pharmacokinetics of PF-06372865 when administered to healthy subjects as single oral doses.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs);

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
  • Screening supine blood pressure > 140 mm Hg (systolic) or >90 mm Hg (diastolic), following at least 5 minutes of supine rest.
  • Any condition possibly affecting drug absorption: current or recent (within one year) gastrointestinal disease; a history of malabsorption, esophageal reflux, irritable bowel syndrome; frequent (more than once a week) occurrence of heartburn; or any surgical intervention (e.g., cholecysectomy) which would be expected to influence the absorption of drugs.

Treatment and study plan

PF-06372865

Drug

7.5 mg as 3 x 2.5 mg tablets single dose

Primary outcomes

  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

    Time frame: basline to 48 hours

    AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).

  2. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Time frame: basline to 48 hours

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  3. Maximum Observed Plasma Concentration (Cmax)

    Time frame: basline to 48 hours

  4. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: basline to 48 hours

  5. Plasma Decay Half-Life (t1/2)

    Time frame: basline to 48 hours

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Secondary outcomes

  1. Change from Baseline in Systolic Blood Pressure

    Time frame: basline to 48 hours

    Value at time T minus value at baseline.

  2. Change from Baseline in Diastolic Blood Pressure

    Time frame: basline to 48 hours

    Value at time T minus value at baseline.

  3. Change from baseline in heart rate

    Time frame: basline to 48 hours

    value at time T minus value at baseline

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Cross-over, Randomized, Single-dose Open Label Study To Determine The Effect Of Food On The Pharmacokinetics Of Orally Administered Pf-06372865 In Healthy Adult Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 15, 2014
Registry last updated
Oct 27, 2014

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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