Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001122640
Ethics application status
Approved
Date submitted
21/07/2014
Date registered
23/10/2014
Date last updated
23/10/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A phase I single ascending dose (SAD) study to investigate the safety, tolerability and pharmacokinetics of oral Capromorelin in spinal cord injury (SCI) and able-bodied volunteers
Scientific title
A single centre, open label, phase I, single ascending dose (SAD) study to investigate the safety, tolerability and pharmacokinetics of oral Capromorelin in spinal cord injury (SCI) and able-bodied volunteers
Secondary ID [1] 285024 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alleviating the effects of autonomic dysfunction following spinal cord injury. 292536 0
Condition category
Condition code
Neurological 292843 292843 0 0
Other neurological disorders
Injuries and Accidents 292962 292962 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single ascending dose study of safety, tolerability and pharmacokinetics of Capromorelin.
Three single ascending oral doses (20, 50 and 100 mg) at least one week apart administered to each of two groups (spinal cord injured and able-bodied).
Participants only progressed to a higher dose after successfully tolerating the prior dose at the lower level.
Intervention code [1] 289858 0
Treatment: Drugs
Comparator / control treatment
Spinal cord injured versus able-bodied group
Control group
Active

Outcomes
Primary outcome [1] 292710 0
Safety.
Assessed by assessment of vital signs, ECG and blood and urine laboratory testing.
Timepoint [1] 292710 0
Immediately following each dose for up to 24 hours, then at 1 week and 3 weeks after final dose.
Primary outcome [2] 292711 0
Tolerability.
Assessed by incidence of adverse events.
No known adverse events. Monitoring of vital signs, physical examination and laboratory test assessment.
Timepoint [2] 292711 0
Immediately following each doseup to 24 hours, then at 1 week and 3 weeks after final dose.
Secondary outcome [1] 309536 0
Pharmacokinetic behaviour.
Assessed by monitoring of plasma levels of the parent drug analysed by a validated liquid chromatography tandem mass spectrometry assay.
Timepoint [1] 309536 0
At each dose level one week apart using a full pharmacokinetic blood sampling profile base on reported plasma half-life of the drug. Sampling from an indwelling catheter in the cubital vein at -30 mins (pre-dose) and at +20 mins, +30 mins, +40m mins, +1 hr, +1.5 hr, +2 hr, +2.5 hr, +3 hr, +3.5 hr, +4 hr, +5 hr, +6 hr, +7 hr, +8 hr and +12 hr post dose.

Eligibility
Key inclusion criteria
With/without spinal cord injury between T6 and T12
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Females of child-bearing potential or who were pregnant or breastfeeding.
Candidates that were unhealthy (as defined by significant deviation from normal medical history or aberrant results from physical examination/ECG/clinical laboratory determinations), or had a history of toxicities or allergy related to previous treatments.
Candidates receiving medications known inhibit /induce CYP3A4.
The non-spinal cord injured group comprised able-bodied volunteers.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Single ascending dose (20mg, 50mg then 100mg dose). Performed in spinal cord injured and able-bodied participants.
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
No power calculations were conducted. A target of n=10 per group was chosen as a reasonable number to start a preliminary study. Rationale being that it was expected to be achievable with the limited nature of the SCI population from which to draw participants and it was sufficient to provide simple comparative statistics. The number of participants per group was deliberately limited with consideration also given to the impact of the intensive blood sampling required for pharmacokinetic analyses.
Non-compartmental pharmacokinetic analyses were performed.
As were parametric statistical analyses for group comparison by analysis of variance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/07/2012
Actual
30/07/2012
Date of last participant enrolment
Anticipated
30/10/2013
Actual
30/10/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2756 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 8458 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 289635 0
Government body
Name [1] 289635 0
Victorian Government Transport Accident Commission
Country [1] 289635 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Level 2 East Medical Building
Grattan St, Parkville VIC 3052

and

Level 5 Lance Townsend Building, Austin Health
145 Studley Rd Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 288324 0
Hospital
Name [1] 288324 0
Austin Health
Address [1] 288324 0
145 Studley Rd Heidelberg
Vic 3084
Country [1] 288324 0
Australia
Other collaborator category [1] 278058 0
Charities/Societies/Foundations
Name [1] 278058 0
Spinal Research Institute
Address [1] 278058 0
Royal Talbot Rehabilitation Centre
1 Yarra Boulevard
Kew Vic 3101
Country [1] 278058 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291376 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 291376 0
Ethics committee country [1] 291376 0
Australia
Date submitted for ethics approval [1] 291376 0
Approval date [1] 291376 0
10/07/2012
Ethics approval number [1] 291376 0
H03988

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

Contacts
Principal investigator
Name 50102 0
Prof Albert Frauman
Address 50102 0
Clinical Pharmacology and Therapeutics
University of Melbourne Department of Medicine
Austin Health
145 Studley Rd Heidelberg Vic 3084
Country 50102 0
Australia
Phone 50102 0
+613 94965486
Fax 50102 0
+613 94593510
Email 50102 0
[email protected]
Contact person for public queries
Name 50103 0
Melinda Millard
Address 50103 0
Spinal Research Coordinator
Austin Health
145 Studley Rd Heidelberg Vic 3084
Country 50103 0
Australia
Phone 50103 0
+613 94965906
Fax 50103 0
+613 94963626
Email 50103 0
[email protected]
Contact person for scientific queries
Name 50104 0
Albert Frauman
Address 50104 0
Clinical Pharmacology and Therapeutics
University of Melbourne Department of Medicine
Austin Health
145 Studley Rd Heidelberg Vic 3084
Country 50104 0
Australia
Phone 50104 0
+613 94965486
Fax 50104 0
+613 94593510
Email 50104 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.