Pharmacodynamics of CGT 2168 Compared With Plavix®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00620802
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : August 26, 2008
Information provided by:
Cogentus Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: CGT-2168 Drug: Plavix Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Randomized, Multiple-Dose, Two-Way Crossover Study of the Pharmacodynamics of CGT 2168 Compared With Plavix®
Study Start Date : November 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A
CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg)
Drug: CGT-2168
(CGT-2168, one capsule each daily)

Active Comparator: B
Plavix (clopidogrel 75 mg)
Drug: Plavix
(clopidogrel, 75 mg)

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Plasma PK measures of clopidogrel (parent drug and carboxylic acid metabolite) with CGT 2168 compared to Plavix®. [ Time Frame: 7 days ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00620802

United States, Kansas
Quintiles Phase I Services
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Cogentus Pharmaceuticals
Study Director: Pablo Lapuerta, MD Cogentus Pharmaceuticals

Responsible Party: Pablo Lapuerta, MD, Cogentus Pharmaceuticals Identifier: NCT00620802     History of Changes
Other Study ID Numbers: CG106
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: August 26, 2008
Last Verified: August 2008

Keywords provided by Cogentus Pharmaceuticals:
Platelet function testing
Healthy volunteers

Additional relevant MeSH terms:
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs