A Phase I, Open-Label, Randomized, Multiple-Dose, Two-Way Crossover Study of the Pharmacodynamics of CGT 2168 Compared With Plavix®
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Cogentus Pharmaceuticals
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 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®.
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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/m
- •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).
Arms & Interventions
B
Plavix (clopidogrel 75 mg)
Intervention: Plavix (Drug)
A
CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg)
Intervention: CGT-2168 (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- 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®.(7 days)
- Plasma PK measures of clopidogrel (parent drug and carboxylic acid metabolite) with CGT 2168 compared to Plavix®.(7 days)