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
Phase 1
Completed
- Conditions
- Alleviating the effects of autonomic dysfunction following spinal cord injury.Neurological - Other neurological disordersInjuries and Accidents - Other injuries and accidents
- Registration Number
- ACTRN12614001122640
- Lead Sponsor
- niversity of Melbourne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
With/without spinal cord injury between T6 and T12
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety.<br>Assessed by assessment of vital signs, ECG and blood and urine laboratory testing.[Immediately following each dose for up to 24 hours, then at 1 week and 3 weeks after final dose. ];Tolerability.<br>Assessed by incidence of adverse events.<br>No known adverse events. Monitoring of vital signs, physical examination and laboratory test assessment. [Immediately following each doseup to 24 hours, then at 1 week and 3 weeks after final dose. ]
- Secondary Outcome Measures
Name Time Method Pharmacokinetic behaviour.<br>Assessed by monitoring of plasma levels of the parent drug analysed by a validated liquid chromatography tandem mass spectrometry assay. [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. ]