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Pharmacodynamics of CGT 2168 Compared With Plavix�

Information source: Cogentus Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: CGT-2168 (Drug); Plavix (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Cogentus Pharmaceuticals

Official(s) and/or principal investigator(s):
Pablo Lapuerta, MD, Study Director, Affiliation: Cogentus Pharmaceuticals

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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®.

Secondary outcome:

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®.

Plasma PK measures of clopidogrel (parent drug and carboxylic acid metabolite) with CGT 2168 compared to Plavix®.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Quintiles Phase I Services, Overland Park, Kansas 66211, United States
Additional Information

Starting date: November 2007
Last updated: August 22, 2008

Page last updated: August 23, 2015

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