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
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
University of Melbourne
20 participants
Jul 30, 2012
Interventional
Conditions
Summary
Capromorelin (CP424391) is a ghrelin receptor agonist which shows evidence of promoting defecation and may be of use in spinal cord injury (SCI) patients to promote bowel movements. The purpose of the study was to evaluate the safety profile, tolerability, pharmacokinetics and pharmacodynamics following single oral doses of 20, 50 and 100 mg of Capromorelin in SCI and in able-bodied participants.
Eligibility
Inclusion Criteria1
- With/without spinal cord injury between T6 and T12
Exclusion Criteria4
- 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.
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Interventions
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.
Locations(1)
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ACTRN12614001122640