Pharmacodynamics of CGT 2168 Compared With Plavix®

NCT ID: NCT00620802

Last Updated: 2008-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2008-05-31

Brief Summary

CG106 is a Phase I open-label, randomized, multiple-dose, two-way crossover study to characterize the pharmacodynamics and pharmacokinetics of the investigational fixed-dose combination product CGT 2168 (clopidogrel, 75 mg and omeprazole, 20 mg) relative to Plavix® (clopidogrel, 75 mg).

Healthy volunteer subjects will undergo two dosing periods. In each 7-day dosing period, subjects will receive oral doses of study drug consisting of open-label CGT 2168 or Plavix® in the order determined by the randomization schedule. Each period of dose administration will be separated by a two-week washout period. Study exit will occur 1 week after Dosing Period 2. The expected total duration of participation is 8 weeks (56 days), including a screening visit on or within 21 days prior to enrollment.

On the day before Day 1 and Day 7 in each dosing period, subjects will be admitted to the Phase I unit. Blood samples to determine ADP-induced platelet aggregation will be collected pre-dose on Day 1 and 2 h after dosing on Day 7. Plasma concentrations of clopidogrel parent and clopidogrel carboxylic acid metabolite will also be measured pre-dose on Day 1 and pre-dose and serially after dosing on Day 7.

Conditions

Healthy

Keywords

Platelet function testing; Healthy volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg)

Group Type: EXPERIMENTAL

CGT-2168

Intervention Type: DRUG

(CGT-2168, one capsule each daily)

B

Plavix (clopidogrel 75 mg)

Group Type: ACTIVE_COMPARATOR

Plavix

Intervention Type: DRUG

(clopidogrel, 75 mg)

Interventions

CGT-2168

(CGT-2168, one capsule each daily)

Intervention Type: DRUG

Plavix

(clopidogrel, 75 mg)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy males and females. Women of childbearing potential must have a negative pregnancy test prior to enrollment and agree to use two methods of effective barrier contraception, or a hormonal contraceptive to prevent pregnancy throughout the study.
• Able to comply with study procedures, which includes returning to the Phase I unit for all scheduled visits and procedures.
• Abstinence from tobacco use (including smoking cessation products containing nicotine) for 90 days prior to study entry, with agreement to abstain from tobacco/nicotine use throughout the study.
• Agreement to abstain from alcohol and caffeine ingestion from 72 h before dosing and throughout each dosing period.
• Able to give informed consent, and subject has signed and dated a written consent form approved by the IRB.

Exclusion Criteria

• Hypersensitivity to clopidogrel, omeprazole, or related drugs including inactive ingredients.
• BMI (body mass index) outside the range of 19-30 kg/m2.
• At screening, body weight less than 50 kg if male or 45 kg if female.
• Clinically significant abnormal findings on physical examination, clinical laboratory tests or ECG at screening.
• History of hypertension or 5-minute sitting screening BP ≥160/100 mmHg on measurements repeated twice.
• History of diabetes mellitus, renal failure, acute or chronic liver disease, including acute or chronic hepatitis, or cirrhosis.
• Positive HIV-1 antibody, hepatitis B surface antigen or hepatitis C antibody screening test.
• History of any clinically significant medical or psychiatric condition.
• Difficulty in swallowing medication, or any known or suspected gastrointestinal abnormality that may affect drug absorption.
• Participation in a previous clinical trial within 30 days prior to enrollment (check-in on Day -1 for Visit 2).
• Blood donation of ≥ 1 pint within 30 days or plasma donation within 14 days prior to enrollment (check-in on Day -1 for Visit 2).
• Use of any prescription or over-the-counter medications or ingestion of herbal drugs/dietary supplements including vitamins and minerals within 14 days prior to enrollment (check-in on Day -1 for Visit 2). Hormonal contraceptives are allowed.
• Subject is not willing to refrain from drinking grapefruit juice or eating grapefruit throughout study participation.
• Subject is an active illicit drug user or has a history of illicit drug use within the previous 12 months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cogentus Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Cogentus Pharmaceuticals

Principal Investigators

Pablo Lapuerta, MD

Role: STUDY_DIRECTOR

Cogentus Pharmaceuticals

Locations

Quintiles Phase I Services

Overland Park, Kansas, United States

Countries

United States

Other Identifiers

CG106

Identifier Type: -

Identifier Source: org_study_id