Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000582853
Ethics application status
Approved
Date submitted
23/05/2012
Date registered
30/05/2012
Date last updated
2/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
An Open-label, Single-dose, 3-Period Crossover Study to Evaluate the 2-way Interaction of Sitagliptin and Losartan in Healthy Adult Subjects
Scientific title
An Open-label, Single-dose, 3-Period Crossover Study to Evaluate the 2-way Interaction of Sitagliptin and Losartan in Healthy Adult Subjects
Secondary ID [1] 280541 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 286517 0
Hypertension 286518 0
Condition category
Condition code
Metabolic and Endocrine 286782 286782 0 0
Diabetes
Cardiovascular 286783 286783 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment A: Sitagliptin 100mg (oral tablet)
Treatment B: Losartan 100mg (oral tablet)
Treatment C: Sitagliptin 100mg (oral tablet) + Losartan 100mg (oral tablet)

Each participant receives each of the treatments (A, B, C) once as a single oral dose with a seven day wash-out period in between doses. The order in which they receive the treatments is randomized.

MK0431G (combination treatment) is being developed for treatment of patients for whom treatment with both Sitagliptin and Losartan is appropriate. However, this study is in healthy volunteers only.
Intervention code [1] 284917 0
Treatment: Drugs
Comparator / control treatment
1/ Sitagliptin 100mg, single oral dose (tablet)
2/ Losartan 100mg, single oral dose (tablet)
Control group
Active

Outcomes
Primary outcome [1] 287174 0
Outcome: The effect of co-administration of sitagliptin and losartan on the AUC 0-infinity of sitagliptin, losartan and the losartan metabolite, E-3174.

Measured by: Pharmacokinetics of sitagliptin, losartan and the losartan metabolite, E-3174
Timepoint [1] 287174 0
Time points: Sitagliptin: Pre-dose and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12,16, 24, 36, 48, and 72 hours post-dose

Losartan, E-3174: Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 18, 24, 30, and 36 hours post-dose

Sitagliptin/Losartan co-administration: separate PK samples collected for Sitagliptin and Losartan, E-3174 at the time points indicated for each above.
Secondary outcome [1] 297554 0
Outcome: The effect of co-administration of sitagliptin and losartan on the pharmacokinetics of sitagliptin, losartan and E-3174 (e.g., Cmax, Tmax, and apparent t1/2).

Measured by: Pharmacokinetics of sitagliptin, losartan and the losartan metabolite, E-3174
Timepoint [1] 297554 0
Time points: Sitagliptin: Pre-dose and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12,16, 24, 36, 48, and 72 hours post-dose

Losartan, E-3174: Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 18, 24, 30,
and 36 hours post-dose

Sitagliptin/Losartan co-administration: separate PK samples collected for Sitagliptin and Losartan, E-3174 at the time points indicated for each above.

Eligibility
Key inclusion criteria
-Subject judged to be in good health based on medical history, physical examination, ECG, vital sign measurements and laboratory safety tests
-Non-smoker
-BMI <30kg/m2
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Mentally or legally incapacitated or having significant emotional problems or has a history of clinically significant psychiatric disorder
-History of any clinically significant diseases/disorders, myopathic disorder or history of rhabdomyolysis.
-Creatinine clearance <80mL/min
-History of neoplastic disease
-Pregnant, breast feeding or expecting to conceive
-Major surgery or blood donation within 4 weeks
-Consumes excessive amounts of alcohol or caffeine
-History of significant allergies, anaphylactic reaction or significant intolerance to prescription/non-prescription drugs or food.
-Regular/recreational drug user
-History of hypersensitivity to sitagliptin, losartan or any of the tablet excipients

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
22/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285301 0
Commercial sector/Industry
Name [1] 285301 0
Merck Sharp and Dohme Corp, a subsidiary of Merck & Co., Inc.
Country [1] 285301 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp and Dohme Corp, a subsidiary of Merck & Co., Inc.
Address
One Merck Drive
Whitehouse Station, NJ, 08889-0100
Country
United States of America
Secondary sponsor category [1] 284162 0
None
Name [1] 284162 0
N/A
Address [1] 284162 0
N/A
Country [1] 284162 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287323 0
Ethics committee address [1] 287323 0
Ethics committee country [1] 287323 0
Date submitted for ethics approval [1] 287323 0
02/05/2012
Approval date [1] 287323 0
Ethics approval number [1] 287323 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34205 0
Address 34205 0
Country 34205 0
Phone 34205 0
Fax 34205 0
Email 34205 0
Contact person for public queries
Name 17452 0
Mr Jeffery Wong
Address 17452 0
Nucleus Network
5th Floor Burnet Tower
AMREP Precinct
89 Commercial Road Melbourne VIC 3004
Country 17452 0
Australia
Phone 17452 0
+613 9496 6729
Fax 17452 0
Email 17452 0
[email protected]
Contact person for scientific queries
Name 8380 0
Associate Professor Peter Hodsman
Address 8380 0
Nucleus Network
5th Floor Burnet Tower
AMREP Precinct
89 Commercial Road Melbourne VIC 3004
Country 8380 0
Australia
Phone 8380 0
+613 9076 8960
Fax 8380 0
Email 8380 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.