HealthyPhase 1NCT00620802
Pharmacodynamics of CGT 2168 Compared With Plavix®
A Phase 1 study testing CGT-2168 and Plavix in people with Healthy, run by Cogentus Pharmaceuticals at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CGT-2168 and Plavix
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to May 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Quintiles Phase I Services
Overland Park, Kansas, 66211
About this study
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.
- Conditions
- Healthy
- Being tested
- CGT-2168, Plavix
- Keywords
- Platelet function testing, Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGT-2168Drug
(CGT-2168, one capsule each daily)
PlavixDrug
(clopidogrel, 75 mg)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg) Receives: Drug: CGT-2168 |
| B | Active comparator | Plavix (clopidogrel 75 mg) Receives: Drug: Plavix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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®.
Measured: 7 days
Secondary outcomes (2)
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®.
Measured: 7 days
Plasma PK measures of clopidogrel (parent drug and carboxylic acid metabolite) with CGT 2168 compared to Plavix®.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startNov 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cogentus Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pablo Lapuerta, MD, Study director, Cogentus Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00620802
- Sponsor's protocol ID
- CG106
- Status last verified
- Aug 2008
- First submitted
- 12 Feb 2008
- Last updated
- 26 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Randomized, Multiple-Dose, Two-Way Crossover Study of the Pharmacodynamics of CGT 2168 Compared With Plavix®
- ClinicalTrials.gov ID
- NCT00620802
- Acronym / sponsor ID
- CG106
- Conditions
- Healthy
- Keywords
- Platelet function testing, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cogentus PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 22 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: CGT-2168CGT-2168 (clopidogrel 75 mg/omeprazole 20 mg) |
| B | Active comparator | Drug: PlavixPlavix (clopidogrel 75 mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGT-2168(CGT-2168, one capsule each daily) | Drug | A |
| Plavix(clopidogrel, 75 mg) | Drug | B |
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®.
Time frame: 7 days
2 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®.
Time frame: 7 days
Plasma PK measures of clopidogrel (parent drug and carboxylic acid metabolite) with CGT 2168 compared to Plavix®.
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Lapuerta, MD study director
Cogentus Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CGT-2168 and Plavix in people with Healthy, run by Cogentus Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2008.