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Completed

NCT Number: NCT00645216

Study Examing The Effect of Grapefruit Juice On The Blood And Urine Samples of Study Drug And Its By Product And Safety

CP-945,598 is eliminated primarily by enzyme CYP3A. Grapefruit juice may affect the activity of CYP3A and alter the amount of CP-945,598 in the blood. This study will therefore compare the time course of drug concentrations in the body, safety and tolerability of CP-945,598 given with or without grapefruit juice in healthy obese/overweight subjects.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

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 female subjects between the ages of 18 and 55 years.
  • Body Mass Index (BMI) of 27 to 40 kg/m2.
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.

Exclusion criteria

  • Non-prescribed use of drugs of abuse/ recreational drugs;
  • Recent treatment with experimental drugs or herbal experiments;
  • EKG and blood pressure parameters falling outside of protocol-specified limits;
  • History of regular alcohol or tobacco use exceeding protocol-specified limits; grapefruit juice intolerance.

Treatment and study plan

CP-945,598

Drug

Subjects take CP-945,598 alone for 21 days

Primary outcomes

  1. Measurement of durg and metabolite concentrations in serum from blood sampling collected at various times over 24 hours dosing interval on Day 7 and 21, before dosing on days 5,6, 12, 13, 14, 19 and 20.

    Time frame: 21 days

  2. Safetey laboratory tests (chemistry, hematology, urinalysis) on Days -1 and 22

    Time frame: 21 days

  3. Adverse event monitoring throughout duration of the study

    Time frame: 21 days

Secondary outcomes

  1. Urinary 6-β-hydroxycortisol:cortisol ratios (CMR) on Days 0 and 21.

    Time frame: 2 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Open Label, Randomized, Fixed Sequence Study To Evaluate The Effect Of Multiple Dose Administration Of Grapefruit Juice On The Multiple Dose Pharmacokinetics Of CP-945,598 In Healthy Overweight And Obese Subjects

Important dates

Study start
2007
Study completion
2007
First posted
Mar 27, 2008
Registry last updated
Aug 10, 2009

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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