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Completed

NCT Number: NCT02151617

A Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of Multiple Oral Doses Of PF-06743649

The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of multiple oral doses of PF-06743649. The pharmacodynamic activity of PF-06743649 will also be assessed. The effect of food on PK of PF-06743649 will also be investigated.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

  • Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • Evidence of gout/hyperuricemia, measured sUA >8 mg/dL at screening.
  • Experienced an episode of nephrolithiasis or ureterolithiasis.

Treatment and study plan

PF-06743649

Drug

40 mg tablet one time once with a meal and once without a meal, followed by once daily dosing for 14 days

Placebo

Drug

Placebo tablet one time once with a meal and once without a meal, followed by once daily dosing for 14 days

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: up to 14 days

  2. Area Under the Curve from Time Zero to end of dosing interval (AUCtau)

    Time frame: up to 14 days

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

    Time frame: up to 14 days

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

    Time frame: up to 14 days

  5. Amount of drug recovered unchanged in urine during the dosing interval (Aetau)

    Time frame: up to 14 days

  6. Percent of dose recovered unchanged in urine during the dosing interval(Aetau%)

    Time frame: up to 14 days

  7. Renal clearance (CLr)

    Time frame: up to 14 days

Secondary outcomes

  1. Change from baseline in serum uric acid level

    Time frame: up to 14 days

  2. Change from baseline in serum levels of xanthine and hypoxanthine

    Time frame: up to 14 days

  3. Urinary uric acid levels

    Time frame: up to 14 days

  4. Urinary xanthine levels

    Time frame: up to 14 days

  5. Urinary hypoxanthine levels

    Time frame: up to 14 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1 Double Blind (3rd Party Open) Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Safety,Tolerability, Pharmacokinetics And Pharmacodynamics Of Repeat Doses Of Pf-06743649 With Or Without Food In Healthy Adult Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 30, 2014
Registry last updated
Jan 19, 2015

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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