Official Title: “A Phase I, Open-Label, Randomized, Multiple-Dose, Two-Way Crossover Study of the Pharmacodynamics of CGT 2168 Compared With Plavix®”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics/Dynamics Study

Study Primary Completion Date: May 2008

Intervention(s) in this Clinical Trial

• Drug: CGT-2168
  • (CGT-2168, one capsule each daily)
• Drug: Plavix
  • (clopidogrel, 75 mg)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg)
• Active Comparator: B
  • Plavix (clopidogrel 75 mg)

Primary Measures

• The primary endpoint of this study is inhibition of platelet aggregation (IPA) based on maximum platelet aggregation (MPA) to 5 and 20 µM ADP after 7 days daily dosing with CGT-2168 compared to Plavix®.
  • Time Frame: 7 days
    Safety Issue?: No

Secondary Measures

• Residual aggregation, measured 10 min after the addition of 20 and 5 µM ADP, after 7 days daily dosing with CGT 2168 compared to Plavix®.
  • Time Frame: 7 days
    Safety Issue?: No
• Plasma PK measures of clopidogrel (parent drug and carboxylic acid metabolite) with CGT 2168 compared to Plavix®.
  • Time Frame: 7 days
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Cogentus Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Pablo Lapuerta, MD Study Director Cogentus Pharmaceuticals  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00620802

Study ID Number: CG106

ClinicalTrials.gov Identifier: NCT00620802

Health Authority: United States: Food and Drug Administration