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Trial registered on ANZCTR


Registration number
ACTRN12614000464662
Ethics application status
Approved
Date submitted
19/04/2014
Date registered
2/05/2014
Date last updated
2/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Single-Dose, Randomized, Open-Label, Crossover, Pilot, Comparative Bioavailability Study of Aprepitant 130 mg Injection Versus EMEND Registered Trademark 150 mg Injection and EMEND Registered Trademark 125 mg Capsules in Healthy Male and Female Volunteers under Fasting Conditions.
Scientific title
A Single-Dose, Randomized, Open-Label, Crossover, Pilot, Comparative Bioavailability Study of Aprepitant 130 mg Injection (InnoPharma, Inc.), EMEND Registered Trademark 150 mg Injection (Merck Sharp & Dohme Corp.) and EMEND Registered Trademark 125 mg Capsules (Merck Sharp & Dohme Corp.) in Healthy Male and Female Volunteers under Fasting Conditions
Secondary ID [1] 284438 0
Nil Known
Universal Trial Number (UTN)
U1111-1155-7090
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emesis 291656 0
Condition category
Condition code
Other 292043 292043 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Aprepitant 130 mg IV Injection (InnoPharma, Inc.); International Non-Proprietary Name is Aprepitant injection; single dose only. At least a 10-hour overnight fasting period, subjects will be dosed and will be required to continue to fast for at least 4 hours after drug administration.
Arm 2: EMEND Registered Trademark 150 mg IV Injection (Merck Sharp & Dohme Corp.); International Non-Proprietary Name is Aprepitant injection; single dose only. At least a 10-hour overnight fasting period, subjects will be dosed and will be required to continue to fast for at least 4 hours after drug administration.
Arm 3: EMEND Registered Trademark 125 mg Oral Capsules (Merck Sharp & Dohme Corp.); International Non-Proprietary Name is Aprepitant Capsule; single dose only. At least a 10-hour overnight fasting period, subjects will be dosed and will be required to continue to fast for at least 4 hours after drug administration.
Washout period is 7 days between each dosing.
Subjects will be confined in the clinical facility from 10 hours prior to drug administration until 24 hours after drug administration for each study period to monitor adherence to treatment.
At least a 10-hour overnight fasting period, subjects will be dosed and will be required to continue to fast for at least 4 hours after drug administration. Following a fasting period of at least 4-hours after drug administration, subjects will be given standardized meals and caffeine/methylxanthine-free beverages at scheduled times. In this study, meals will be served at approximately 4.5, 9.5 and 13.5 hours after drug administration.
Intervention code [1] 289197 0
Treatment: Drugs
Comparator / control treatment
EMEND Registered Trademark 150 mg IV Injection (Merck Sharp & Dohme Corp.) and EMEND Registered Trademark 125 mg Oral Capsules (Merck Sharp & Dohme Corp.)
Control group
Active

Outcomes
Primary outcome [1] 291944 0
The objective of this pilot study is to estimate the intrasubject variability and to compare the bioavailability of aprepitant from Aprepitant 130 mg Injection (InnoPharma, Inc.), EMEND Registered Trademark 150 mg Injection (Merck Sharp & Dohme Corp.) and EMEND Registered Trademark 125 mg Capsules (Merck Sharp & Dohme Corp.) in healthy, non-smoking male and female volunteers under fasting conditions.
Timepoint [1] 291944 0
For Aprepitant 130 mg Injection and EMEND Registered Trademark 150 mg Injection each: pre-dose, and at 5, 10 and 20 minutes (during infusion), and after infusion at 5, 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours after infusion.

EMEND Registered Trademark 125 mg Capsules: pre-dose, and at 10 and 20 minutes, and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours after dosing.
Secondary outcome [1] 307903 0
nil
Timepoint [1] 307903 0
nil

Eligibility
Key inclusion criteria
Healthy male and female; non-smoking; BMI that is within 18.5-29.9 kg/m^2, inclusive; Systolic blood pressure between 95-140 mmHg, inclusive, and diastolic blood pressure between 55-90 mmHg, inclusive, and heart rate between 50-100 bpm, inclusive; Ability to fast for at least 14 hours and consume standard meal; Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals who have participated in another clinical trial or who received an investigational drug within 30 days prior to first drug administration; Consumption of food or beverages containing caffeine/methylxanthines, poppy seeds and/or alcohol within 48 hours before dosing and containing grapefruit and/or pomelo within 10 days prior to first drug administration; Use of any prescription medication within 14 days prior to first drug administration

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
In this study, the assignment of treatment groups will be generated by a computer program designed and run in SAS, producing a balanced random allocation of subjects into treatment sequences known as the randomization scheme. Subjects will be assigned consecutive subject numbers in an ascending order. This number will identify the subject and determine the treatment sequence the subject will undergo. Treatment assignment will be described in the randomization scheme.

Each subject is scheduled to receive a total of three treatments by the end of the study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 0
Type of endpoint/s
Bio-availability
Statistical methods / analysis
Analysis of Variance (ANOVA) for ln-transformed AUCt, AUCinf and Cmax, and untransformed Tmax, lambda (decay constant) and half-life. Tmax will also be analyzed using an additional non-parametric test (Wilcoxon test). The 90% confidence intervals (CI) for the Test/Reference ratios of geometric means for AUCt, AUCinf and Cmax will be calculated based on the least square means (LSMEANS) and ESTIMATE of the ANOVA.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/04/2014
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)
SA
Recruitment hospital [1] 2350 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 8015 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 289107 0
Commercial sector/Industry
Name [1] 289107 0
InnoPharma, Inc.
Country [1] 289107 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
InnoPharma, Inc.
Address
10 Knightsbridge Road, Suite III,
Piscataway, New Jersey
08854
Country
United States of America
Secondary sponsor category [1] 287773 0
None
Name [1] 287773 0
Address [1] 287773 0
Country [1] 287773 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290894 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 290894 0
129 Glen Osmond Road,
Eastwood SA 5063
Ethics committee country [1] 290894 0
Australia
Date submitted for ethics approval [1] 290894 0
05/03/2014
Approval date [1] 290894 0
11/04/2014
Ethics approval number [1] 290894 0
2014-03-117

Summary
Brief summary
The objective of this pilot study is to estimate the intrasubject variability and to compare the bioavailability of aprepitant from Aprepitant 130 mg Injection (InnoPharma, Inc.), EMEND Registered Trademark 150 mg Injection (Merck Sharp & Dohme Corp.) and EMEND Registered Trademark 125 mg Capsules (Merck Sharp & Dohme Corp.) in healthy, non-smoking male and female volunteers under fasting conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47726 0
Dr Sepehr Shakib
Address 47726 0
Level 5 East Wing Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 47726 0
Australia
Phone 47726 0
+61 8 8222 3923
Fax 47726 0
+61 8 8223 3475
Email 47726 0
[email protected]
Contact person for public queries
Name 47727 0
Jane Kelly
Address 47727 0
Level 5 East Wing Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 47727 0
Australia
Phone 47727 0
+61 8 8222 3872
Fax 47727 0
+61 8 8223 3475
Email 47727 0
[email protected]
Contact person for scientific queries
Name 47728 0
Jane Kelly
Address 47728 0
Level 5 East Wing Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 47728 0
Australia
Phone 47728 0
+61 8 8222 3872
Fax 47728 0
+61 8 8223 3475
Email 47728 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
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Documents added automatically
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