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

This study has been completed.

Study NCT00942175 Information provided by Takeda Global Research & Development Center, Inc.

First Received on July 16, 2009. Last Updated on February 1, 2012 History of Changes

Results First Received: May 31, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacokinetics/Dynamics Study; Intervention Model: Crossover Assignment; Masking: Open Label
Condition:	Healthy
Interventions:	Drug: Clopidogrel Drug: Clopidogrel and Lansoprazole Drug: Clopidogrel and Dexlansoprazole Drug: Clopidogrel and Omeprazole Drug: Clopidogrel and Esomeprazole

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants enrolled at one site in the United States from 15 December 2009 to 08 July 2010.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Healthy participants were enrolled in one of 4, once-daily (QD), proton pump inhibitor (PPI) treatment groups.

Reporting Groups

	Description
PPI Group 1	Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days. Regimen B: Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
PPI Group 2	Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days. Regimen C: Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
PPI Group 3	Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days. Regimen D: Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
PPI Group 4	Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days. Regimen E: Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.

Participant Flow: Overall Study

	PPI Group 1	PPI Group 2	PPI Group 3	PPI Group 4
STARTED	40	40	40	40
COMPLETED	38	36	38	38
NOT COMPLETED	2	4	2	2
Adverse Event	2	1	0	0
Protocol Violation	0	1	2	0
Pregnancy	0	0	0	1
Elevated Alanine Amino Transferase	0	0	0	1
Low Platelet Count	0	2	0	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
PPI Group 1	Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days. Regimen B: Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
PPI Group 2	Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days. Regimen C: Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
PPI Group 3	Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days. Regimen D: Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
PPI Group 4	Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days. Regimen E: Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.

Baseline Measures

	PPI Group 1	PPI Group 2	PPI Group 3	PPI Group 4	Total
Number of Participants [units: participants]	40	40	40	40	160
Age [units: years] Mean ± Standard Deviation	32.8 ± 6.48	35.7 ± 7.92	34.0 ± 7.40	33.3 ± 7.10	33.9 ± 7.26
Gender [units: participants]
Female	20	20	20	20	80
Male	20	20	20	20	80

Outcome Measures

Show All Outcome Measures

1. Primary:

Pharmacokinetic Parameter Peak Plasma Concentration (Cmax) of Clopidogrel’s Active Metabolite. [ Time Frame: Day 9 of each period ]

Show Outcome Measure 1

2. Primary:

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 ]

Show Outcome Measure 2

3. Primary:

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. ]

Show Outcome Measure 3

4. Primary:

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. ]

Show Outcome Measure 4

5. Primary:

Pharmacodynamic Parameter MPA From Aggregometry (Turbidimetric) With 20 µM Adenosine Diphosphate. [ Time Frame: 24-hour post Day 9 dose in each period. ]

Show Outcome Measure 5

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights therefrom or any data, information or materials obtained or generated in the performance of it’s obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda’s sole discretion.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Sr. VP, Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com

No publications provided

Responsible Party:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00942175 History of Changes
Other Study ID Numbers:	TAK-390MR_101, U1111-1112-6792
Study First Received:	July 16, 2009
Results First Received:	May 31, 2011
Last Updated:	February 1, 2012
Health Authority:	United States: Food and Drug Administration