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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614001122640

Enrollment

Registered

2014-10-23

Start date

2012-07-30

Completion date

2013-10-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

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.

Outcome results