HealthyPhase 1NCT00942175

A Study of the Effects of Multiple Doses of Dexlansoprazole, Lansoprazole, Omeprazole or Esomeprazole on the Pharmacokinetics and Pharmacodynamics of Clopidogrel in Healthy Participants.

A Phase 1 study testing Clopidogrel, Clopidogrel and Lansoprazole and Clopidogrel and Dexlansoprazole in people with Healthy, run by Takeda at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the potential effect and safety of multiple oral doses of dexlansoprazole, lansoprazole, omeprazole or esomeprazole, once daily (QD), on the steady-state pharmacokinetics and pharmacodynamics of clopidogrel, and to assess the safety of multiple doses of clopidogrel in healthy… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Clopidogrel, Clopidogrel and Lansoprazole and Clopidogrel and Dexlansoprazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 1 siteUnited States
Study dates: Dec 2009to Jul 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

The participant or the participant's legally acceptable representative signs a written, informed consent form prior to the initiation of any study procedures.
Weighs at least 50 kg and has a body mass index (BMI) between 18 and 30 kg/m2, inclusive, at Screening and Check-in (Day -1 of Period 1) Visits.
Must be a CYP2C19 extensive metabolizer (wt/wt).
Females cannot be nursing and must have a negative urine pregnancy test at Day -1 or be of non-childbearing potential. If females are of child bearing potential, must have a negative serum human chorionic gonadotropin (hCG) pregnancy test during Screening and on an acceptable form of contraception, or have had bilateral tubal ligation if performed a minimum of 90 days prior to Day 1.
At the Screening and Check-in (Day -1 of Period 1) Visits, must have an estimated creatinine clearance (CLcr) greater than or equal 90 mL/minute as determined from the Cockcroft-Gault formula.
Is in good health as determined by a physician based upon medical history, electrocardiogram, and physical examination findings at the Screening and Check-in (Day -1 of Period 1) Visits.
Participant's clinical laboratory evaluations (including hematology, clinical chemistry [fasted for a least 8 hours], and urinalysis) at the Screening and Check-in (Day -1 of Period 1) Visits are within the reference range for the testing laboratory or are deemed not clinically significant by the investigator and TGRD Medical Monitor.
Participant's urine drug screen for selected substances of abuse is negative at the Screening and Check-in (Day -1 of Period 1) Visits.

Who cannot join

Has consumed products containing Seville oranges (sour), grapefruit or grapefruit juice within 14 days prior to the first dose of study drug or is unwilling to agree to abstain from products containing Seville oranges (sour), grapefruit or grapefruit juice while participating in the study.
Has current or recent (within 6 months) gastrointestinal disease, a history of malabsorption, esophageal reflux, gastric bleeding or peptic ulcer disease, frequent (more than once per week) occurrence of heartburn, or any surgical intervention (eg, cholecystectomy), which would be expected to influence the absorption of drugs.
Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as the consumption of more than 4 alcoholic beverages per day) within 1 year prior to the Screening Visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
Is currently participating in another investigational study or has received any investigational compound within 30 days prior to the Check-in (Day -1 of Period 1) Visit.
Has received any known hepatic or renal clearance altering agents (eg, erythromycin, cimetidine, barbiturates, phenothiazines, fluvoxamine, etc.) within 28 days prior to first dose of study drug.
Has a history or clinical manifestations of significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urologic, immunologic, or psychiatric disorder as determined by the investigator which may impact the ability of the participant to take part in or potentially confound the trial results.

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Has a history of hypersensitivity or allergies to any drug or food or any excipients of clopidogrel, lansoprazole, dexlansoprazole, omeprazole, esomeprazole or other drug with the same mechanism of action or related compounds.
Has had an acute, clinically significant illness within 30 days prior to the first dose of study drug.
Has a systolic blood pressure greater than 140 mm Hg or has a diastolic blood pressure greater than 90 mm Hg at Screening or Check-in (Day -1 of Period 1).
Has a positive test result for hepatitis B surface antigen (HBsAg) or antibody to hepatitis C virus (anti-HCV) at Screening, or a known history of infection with the human immunodeficiency virus (HIV).
Has a Day -1 laboratory value assessed by the principal investigator and sponsor medical monitor as clinically significant underlying disease or condition that may prevent the participant from entering the study.
Has an alanine aminotransferase, aspartate aminotransferase or Total Bilirubin level that exceeds the upper limit of normal at the Screening or Check-in (Day -1 of Period 1) Visits.
Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 6 weeks prior to Check-in (Day -1 of Period 1) Visit, or has a positive cotinine screen at the Screening or Check-in (Day - 1 of Period 1) Visits or anticipates an inability to abstain from these products for the duration of the study.
With the exception of acetaminophen, has taken any excluded medication, supplements or food products listed in the Excluded Dietary Items and Medications table located in the study protocol.
Has donated blood products (such as plasma) within 30 days, or has donated whole blood or had a significant blood loss (500 mL) within 56 days of the first dose of study drug
Has a positive test result for caffeine at the Check-in (Day -1 of Period 1) Visit.
Has a history of cancer, except basal cell carcinoma, which has not been in remission for at least 5 years prior to the first dose of study drug.
Has received clopidogrel or any PPIs or histamine2-receptor antagonists within 28 days of screening.
Participant, in the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Tempe, Arizona

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Open-Label, 2-Period, Crossover Design Study to Assess the Effects of Multiple Oral Doses of Dexlansoprazole, Lansoprazole, Omeprazole or Esomeprazole on the Steady-State Pharmacokinetics and Pharmacodynamics of Clopidogrel in Healthy Subjects

Read the detailed description

This is a Phase 1, randomized, open-label, single-center, multiple-dose, 2-period, crossover study to assess the effects of multiple oral doses of dexlansoprazole, lansoprazole, omeprazole or esomeprazole on the steady-state pharmacokinetics (PK) and pharmacodynamics (PD) of clopidogrel in healthy participants.

Participants were randomized equally into eight regimen sequence groups, 20 participants each. Participants randomized to Sequence Groups 1 and 2, 3 and 4, 5 and 6 and 7 and 8 were called proton pump inhibitor (PPI) Groups 1, 2, 3, and 4, respectively. Each sequence group consists of 2 regimens. Sequence Groups 1, 3, 5 and 7 dosed Regimen A (75 mg clopidogrel) for Days 1-9 of Period 1 and then crossed over to one of the following 4 regimens for Days 1-9 of Period 2: Regimen B (75 mg clopidogrel + 30 mg lansoprazole), Regimen C (75 mg clopidogrel + 60 mg dexlansoprazole), Regimen D (75 mg clopidogrel + 80 mg [2x40 mg] omeprazole), or Regimen E (75 mg clopidogrel + 40 mg esomeprazole). Sequence Groups 2, 4, 6 and 8 began with either Regimen B, C, D or E for Period 1 and then crossed over to Regimen A for Period 2.

On Day 9 of each period, blood samples were collected at predose and for 24 hours postdose to measure plasma concentrations of the active metabolite of clopidogrel. Platelet function was assessed daily prior to the dose of clopidogrel on Days 7-9 and 24-hours post Day 9 dose in each period. There was a washout interval of 10 to 14 days between the last dose of study drug in Period 1 and the first dose of study drug in Period 2.

Study participants were confined to the study center for 10 consecutive nights in Period 1, followed by a 10- to 14-day washout interval and confined for an additional 10 consecutive nights in Period 2.

Conditions: Healthy
Being tested: Clopidogrel, Clopidogrel and Lansoprazole, Clopidogrel and Dexlansoprazole, Clopidogrel and Omeprazole, Clopidogrel and Esomeprazole
Keywords: Pharmacology, Stomach Ulcer, Esophagitis, Peptic, Zollinger-Ellison Syndrome, Platelet function, PPI, clopidogrel, Pharmacokinetics and Pharmacodynamics
Medical subject headings: Stomach Ulcer, Esophagitis, Peptic, Zollinger-Ellison Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ClopidogrelDrug
Also called Plavix
Clopidogrel 75 mg, tablets, orally, once daily days 1-9.
Clopidogrel and LansoprazoleDrug
Also called Plavix, Prevacid, AG-1749
Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily days 1-9.
Clopidogrel and DexlansoprazoleDrug
Also called Plavix, Kapidex, TAK-390MR
Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily days 1-9.
Clopidogrel and OmeprazoleDrug
Also called Plavix
Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily days 1-9.
Clopidogrel and EsomeprazoleDrug
Also called Plavix, Nexium
Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily days 1-9.

Study groups in NCT00942175
Study group	Role	What they receive
Regimen A	Other	Clopidogrel 75 mg QD Receives: Drug: Clopidogrel
Regimen B	Other	Clopidogrel 75 mg QD and Lansoprazole 30 mg QD Receives: Drug: Clopidogrel and Lansoprazole
Regimen C	Other	Clopidogrel 75 mg QD and Dexlansoprazole 60 mg QD Receives: Drug: Clopidogrel and Dexlansoprazole
Regimen D	Other	Clopidogrel 75 mg QD and Omeprazole 80 mg QD Receives: Drug: Clopidogrel and Omeprazole
Regimen E	Other	Clopidogrel 75 mg QD and Esomeprazole 40 mg QD Receives: Drug: Clopidogrel and Esomeprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetic Parameter Peak Plasma Concentration (Cmax) of Clopidogrel's Active Metabolite.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: Day 9 of each period
Pharmacokinetic Parameter Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]) of Clopidogrel's Active Metabolite.
Area under the plasma concentration versus time curve (AUC(0-tlqc)) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).
Measured: Day 9 of each period
Pharmacodynamic Parameter Platelet Reactivity Index (PRI) From Vasodilator-stimulated Phosphoprotein (VASP) Phosphorylation State (Flow Cytometry).
PRI is the platelet reactivity index from VASP phosphorylation state (flow cytometry).
Measured: 24-hour post Day 9 dose in each period.
Pharmacodynamic Parameter Maximum Platelet Aggregation (MPA) From Aggregometry (Turbidimetric) With 5 µM Adenosine Diphosphate.
Maximum platelet aggregation (MPA) from aggregometry (turbidimetric) with 5 µM adenosine diphosphate.
Measured: 24-hour post Day 9 dose in each period.
Pharmacodynamic Parameter MPA From Aggregometry (Turbidimetric) With 20 µM Adenosine Diphosphate.
MPA from aggregometry (turbidimetric) with 20 µM adenosine diphosphate.
Measured: 24-hour post Day 9 dose in each period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2009Jul 2010

First posted20 Jul 2009 (estimated)
Study startDec 2009
Primary completionJun 2010
Study completionJul 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
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
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00942175
Sponsor's protocol ID: TAK-390MR_101
Other IDs: U1111-1112-6792
Status last verified: Feb 2012
First submitted: 16 Jul 2009
Last updated: 3 Feb 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Frelinger AL 3rd, Bhatt DL, Lee RD, Mulford DJ, Wu J, Nudurupati S, Nigam A, Lampa M, Brooks JK, Barnard MR, Michelson AD. Clopidogrel pharmacokinetics and pharmacodynamics vary widely despite exclusion or control of polymorphisms (CYP2C19, ABCB1, PON1), noncompliance, diet, smoking, co-medications (including proton pump inhibitors), and pre-existent variability in platelet function. J Am Coll Cardiol. 2013 Feb 26;61(8):872-9. doi: 10.1016/j.jacc.2012.11.040. Epub 2013 Jan 16.
PubMed 23333143
Frelinger AL 3rd, Lee RD, Mulford DJ, Wu J, Nudurupati S, Nigam A, Brooks JK, Bhatt DL, Michelson AD. A randomized, 2-period, crossover design study to assess the effects of dexlansoprazole, lansoprazole, esomeprazole, and omeprazole on the steady-state pharmacokinetics and pharmacodynamics of clopidogrel in healthy volunteers. J Am Coll Cardiol. 2012 Apr 3;59(14):1304-11. doi: 10.1016/j.jacc.2011.12.024.
PubMed 22464259

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Open-Label, 2-Period, Crossover Design Study to Assess the Effects of Multiple Oral Doses of Dexlansoprazole, Lansoprazole, Omeprazole or Esomeprazole on the Steady-State Pharmacokinetics and Pharmacodynamics of Clopidogrel in Healthy Subjects
ClinicalTrials.gov ID: NCT00942175
Acronym / sponsor ID: TAK-390MR_101
Conditions: Healthy
Keywords: Pharmacology, Stomach Ulcer, Esophagitis, Peptic, Zollinger-Ellison Syndrome, Platelet function, PPI, clopidogrel, Pharmacokinetics and Pharmacodynamics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: Jun 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 20 Jul 2009 (estimated)
Results: Posted 7 Sep 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Regimen A	Other	Drug: ClopidogrelClopidogrel 75 mg QD
Regimen B	Other	Drug: Clopidogrel and LansoprazoleClopidogrel 75 mg QD and Lansoprazole 30 mg QD
Regimen C	Other	Drug: Clopidogrel and DexlansoprazoleClopidogrel 75 mg QD and Dexlansoprazole 60 mg QD
Regimen D	Other	Drug: Clopidogrel and OmeprazoleClopidogrel 75 mg QD and Omeprazole 80 mg QD
Regimen E	Other	Drug: Clopidogrel and EsomeprazoleClopidogrel 75 mg QD and Esomeprazole 40 mg QD

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

The participant or the participant's legally acceptable representative signs a written, informed consent form prior to the initiation of any study procedures.
Weighs at least 50 kg and has a body mass index (BMI) between 18 and 30 kg/m2, inclusive, at Screening and Check-in (Day -1 of Period 1) Visits.
Must be a CYP2C19 extensive metabolizer (wt/wt).
Females cannot be nursing and must have a negative urine pregnancy test at Day -1 or be of non-childbearing potential. If females are of child bearing potential, must have a negative serum human chorionic gonadotropin (hCG) pregnancy test during Screening and on an acceptable form of contraception, or have had bilateral tubal ligation if performed a minimum of 90 days prior to Day 1.
At the Screening and Check-in (Day -1 of Period 1) Visits, must have an estimated creatinine clearance (CLcr) greater than or equal 90 mL/minute as determined from the Cockcroft-Gault formula.

Key exclusion criteria (19 listed)

Has consumed products containing Seville oranges (sour), grapefruit or grapefruit juice within 14 days prior to the first dose of study drug or is unwilling to agree to abstain from products containing Seville oranges (sour), grapefruit or grapefruit juice while participating in the study.
Has current or recent (within 6 months) gastrointestinal disease, a history of malabsorption, esophageal reflux, gastric bleeding or peptic ulcer disease, frequent (more than once per week) occurrence of heartburn, or any surgical intervention (eg, cholecystectomy), which would be expected to influence the absorption of drugs.
Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as the consumption of more than 4 alcoholic beverages per day) within 1 year prior to the Screening Visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
Is currently participating in another investigational study or has received any investigational compound within 30 days prior to the Check-in (Day -1 of Period 1) Visit.
Has received any known hepatic or renal clearance altering agents (eg, erythromycin, cimetidine, barbiturates, phenothiazines, fluvoxamine, etc.) within 28 days prior to first dose of study drug.

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
ClopidogrelAlso: PlavixClopidogrel 75 mg, tablets, orally, once daily days 1-9.	Drug	Regimen A
Clopidogrel and LansoprazoleAlso: Plavix, Prevacid, AG-1749Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily days 1-9.	Drug	Regimen B
Clopidogrel and DexlansoprazoleAlso: Plavix, Kapidex, TAK-390MRClopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily days 1-9.	Drug	Regimen C
Clopidogrel and OmeprazoleAlso: PlavixClopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily days 1-9.	Drug	Regimen D
Clopidogrel and EsomeprazoleAlso: Plavix, NexiumClopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily days 1-9.	Drug	Regimen E

Primary outcome

Pharmacokinetic Parameter Peak Plasma Concentration (Cmax) of Clopidogrel's Active Metabolite.
Time frame: Day 9 of each period
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Pharmacokinetic Parameter Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]) of Clopidogrel's Active Metabolite.
Time frame: Day 9 of each period
Area under the plasma concentration versus time curve (AUC(0-tlqc)) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).
Pharmacodynamic Parameter Platelet Reactivity Index (PRI) From Vasodilator-stimulated Phosphoprotein (VASP) Phosphorylation State (Flow Cytometry).
Time frame: 24-hour post Day 9 dose in each period.
PRI is the platelet reactivity index from VASP phosphorylation state (flow cytometry).
Pharmacodynamic Parameter Maximum Platelet Aggregation (MPA) From Aggregometry (Turbidimetric) With 5 µM Adenosine Diphosphate.
Time frame: 24-hour post Day 9 dose in each period.
Maximum platelet aggregation (MPA) from aggregometry (turbidimetric) with 5 µM adenosine diphosphate.
Pharmacodynamic Parameter MPA From Aggregometry (Turbidimetric) With 20 µM Adenosine Diphosphate.
Time frame: 24-hour post Day 9 dose in each period.
MPA from aggregometry (turbidimetric) with 20 µM adenosine diphosphate.

Results and safety

Results posted to the registry on 7 Sep 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PPI Group 1	40	38
PPI Group 2	40	36
PPI Group 3	40	38
PPI Group 4	40	38

Primary outcome: Pharmacokinetic Parameter Peak Plasma Concentration (Cmax) of Clopidogrel's Active Metabolite.

Time frame: Day 9 of each period. Mean (Standard Deviation). Unit: ng/mL

Measure	PPI Group 1: Regimen A n = 38	PPI Group 1: Regimen B n = 38	PPI Group 2: Regimen A n = 36	PPI Group 2: Regimen C n = 36	PPI Group 3: Regimen A n = 38	PPI Group 3: Regimen D n = 38	PPI Group 4: Regimen A n = 38	PPI Group 4: Regimen E n = 38
Value	39.14 (12.553)	30.01 (15.264)	38.85 (15.699)	29.33 (12.400)	38.25 (12.461)	22.55 (10.682)	40.98 (22.908)	24.69 (10.641)

PPI Group 1: Regimen A vs PPI Group 1: Regimen B: Mean Difference (Final Values): 0.7000 (90% CI 0.6106 to 0.8026)
PPI Group 2: Regimen A vs PPI Group 2: Regimen C: Mean Difference (Final Values): 0.7340 (90% CI 0.6516 to 0.8269)
PPI Group 3: Regimen A vs PPI Group 3: Regimen D: Mean Difference (Final Values): 0.5564 (90% CI 0.4877 to 0.6347)

Population analysed: All participants who had valid parameter estimates for both regimens within a PPI group were included in the pharmacokinetics (PK) statistical analyses for this parameter.

Primary outcome: Pharmacokinetic Parameter Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]) of Clopidogrel's Active Metabolite.

Time frame: Day 9 of each period. Mean (Standard Deviation). Unit: ng*hr/ML

Measure	PPI Group 1: Regimen A n = 38	PPI Group 1: Regimen B n = 38	PPI Group 2: Regimen A n = 36	PPI Group 2: Regimen C n = 36	PPI Group 3: Regimen A n = 38	PPI Group 3: Regimen D n = 38	PPI Group 4: Regimen A n = 38	PPI Group 4: Regimen E n = 38
Value	41.69 (10.020)	36.42 (10.825)	41.25 (14.690)	37.75 (13.132)	37.78 (12.043)	26.28 (8.800)	42.35 (18.785)	31.23 (9.938)

PPI Group 1: Regimen A vs PPI Group 1: Regimen B: Mean Difference (Final Values): 0.8573 (90% CI 0.8020 to 0.9165)
PPI Group 2: Regimen A vs PPI Group 2: Regimen C: Mean Difference (Final Values): 0.9103 (90% CI 0.8567 to 0.9672)
PPI Group 3: Regimen A vs PPI Group 3: Regimen D: Mean Difference (Final Values): 0.6943 (90% CI 0.6438 to 0.7487)

Population analysed: All participants who had valid parameter estimates for both formulations within PPI groups were included in the PK statistical analyses for those parameters.

Primary outcome: Pharmacodynamic Parameter Platelet Reactivity Index (PRI) From Vasodilator-stimulated Phosphoprotein (VASP) Phosphorylation State (Flow Cytometry).

Time frame: 24-hour post Day 9 dose in each period.. Mean (Standard Deviation). Unit: percent inhibition

Measure	PPI Group 1: Regimen A n = 38	PPI Group 1: Regimen B n = 38	PPI Group 2: Regimen A n = 36	PPI Group 2: Regimen C n = 36	PPI Group 3: Regimen A n = 38	PPI Group 3: Regimen D n = 38	PPI Group 4: Regimen A n = 38	PPI Group 4: Regimen E n = 38
Value	42.3 (14.61)	46.4 (16.44)	41.3 (15.45)	43.0 (16.47)	47.9 (15.70)	59.1 (17.87)	46.5 (17.28)	58.0 (14.64)

PPI Group 1: Regimen A vs PPI Group 1: Regimen B: Mean Difference (Final Values): 4.1016 (90% CI 0.0348 to 8.1684)
PPI Group 2: Regimen A vs PPI Group 2: Regimen C: Mean Difference (Final Values): 2.0474 (90% CI -0.8555 to 4.9503)
PPI Group 3: Regimen A vs PPI Group 3: Regimen D: Mean Difference (Final Values): 11.0407 (90% CI 6.5219 to 15.5595)

Population analysed: All participants who had valid parameter estimates for both regimens within a PPI group were included in the pharmacodynamics (PD) statistical analyses for this parameter.

Primary outcome: Pharmacodynamic Parameter Maximum Platelet Aggregation (MPA) From Aggregometry (Turbidimetric) With 5 µM Adenosine Diphosphate.

Time frame: 24-hour post Day 9 dose in each period.. Mean (Standard Deviation). Unit: percentage of MPA

Measure	PPI Group 1: Regimen A n = 38	PPI Group 1: Regimen B n = 38	PPI Group 2: Regimen A n = 36	PPI Group 2: Regimen C n = 36	PPI Group 3: Regimen A n = 37	PPI Group 3: Regimen D n = 37	PPI Group 4: Regimen A n = 38	PPI Group 4: Regimen E n = 38
Value	28.1 (6.76)	30.8 (9.35)	34.6 (14.23)	36.2 (16.87)	34.2 (12.32)	42.5 (14.74)	29.3 (10.41)	38.2 (17.77)

PPI Group 1: Regimen A vs PPI Group 1: Regimen B: p = 0.035, ANOVA
PPI Group 2: Regimen A vs PPI Group 2: Regimen C: p = 0.445, ANOVA
PPI Group 3: Regimen A vs PPI Group 3: Regimen D: p <0.001, ANOVA

Population analysed: All participants who had valid parameter estimates for both formulations within PPI groups were included in the PD statistical analyses for those parameters.

Adverse events

Time frame: Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PPI Group 1: Regimen A	0 of 40 (0%)	13 of 39 (33.3%)	Not reported
PPI Group 1: Regimen B	0 of 40 (0%)	16 of 39 (41%)	Not reported
PPI Group 2: Regimen A	0 of 40 (0%)	19 of 39 (48.7%)	Not reported
PPI Group 2: Regimen C	1 of 40 (2.5%)	16 of 38 (42.1%)	Not reported
PPI Group 3: Regimen A	0 of 40 (0%)	14 of 40 (35%)	Not reported
PPI Group 3: Regimen D	0 of 40 (0%)	11 of 38 (28.9%)	Not reported
PPI Group 4: Regimen A	0 of 40 (0%)	17 of 39 (43.6%)	Not reported
PPI Group 4: Regimen E	0 of 40 (0%)	15 of 39 (38.5%)	Not reported

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Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23333143Frelinger AL 3rd, Bhatt DL, Lee RD, Mulford DJ, Wu J, Nudurupati S, Nigam A, Lampa M, Brooks JK, Barnard MR, Michelson AD. Clopidogrel pharmacokinetics and pharmacodynamics vary widely despite exclusion or control of polymorphisms (CYP2C19, ABCB1, PON1), noncompliance, diet, smoking, co-medications (including proton pump inhibitors), and pre-existent variability in platelet function. J Am Coll Cardiol. 2013 Feb 26;61(8):872-9. doi: 10.1016/j.jacc.2012.11.040. Epub 2013 Jan 16.
Derived from this study: PubMed 22464259Frelinger AL 3rd, Lee RD, Mulford DJ, Wu J, Nudurupati S, Nigam A, Brooks JK, Bhatt DL, Michelson AD. A randomized, 2-period, crossover design study to assess the effects of dexlansoprazole, lansoprazole, esomeprazole, and omeprazole on the steady-state pharmacokinetics and pharmacodynamics of clopidogrel in healthy volunteers. J Am Coll Cardiol. 2012 Apr 3;59(14):1304-11. doi: 10.1016/j.jacc.2011.12.024.
Dexilant Package InsertLink provided by the sponsor.

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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.

Medical Director Clinical Science study director

Takeda

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 Clopidogrel, Clopidogrel and Lansoprazole and Clopidogrel and Dexlansoprazole in people with Healthy, run by Takeda 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 8 inclusion and 19 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 3 Feb 2012. 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?

Yes. Results are posted in the registry (first posted 7 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pharmacokinetic Parameter Peak Plasma Concentration (Cmax) of Clopidogrel's Active Metabolite. (time frame: Day 9 of each period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00942175, which also lists 2 linked publications.

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 3 Feb 2012.