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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00645216

Enrollment

Registered

2008-03-27

Start date

2007-06-30

Completion date

2007-10-31

Last updated

2009-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

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.

Interventions

DRUGCP-945,598

Subjects take CP-945,598 alone for 21 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy male and female subjects between the ages of 18 and 55 years. 2. Body Mass Index (BMI) of 27 to 40 kg/m2. 3. 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.

Design outcomes

Primary

Measure	Time frame
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.	21 days
Safetey laboratory tests (chemistry, hematology, urinalysis) on Days -1 and 22	21 days
Adverse event monitoring throughout duration of the study	21 days

Secondary

Measure	Time frame
Urinary 6-β-hydroxycortisol:cortisol ratios (CMR) on Days 0 and 21.	2 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026