Healthy
Conditions
Keywords
Platelet function testing, Healthy volunteers
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.
Interventions
DRUGCGT-2168
(CGT-2168, one capsule each daily)
DRUGPlavix
(clopidogrel, 75 mg)
Sponsors
Cogentus Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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®. | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed