Healthy
Conditions
Keywords
Phase 1, Single Ascending Dose, Health volunteer
Brief summary
A study in healthy volunteers to evaluate the safety, tolerability and pharmacokinetics of OCT461201. The study included a screening period, a single dose of study treatment or placebo and a follow up period.
Detailed description
A phase 1, randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of OCT461201 in healthy participants following ascending single doses. The study comprised a screening period (Day -35 to Day -2), a treatment period (Day -1 to Day 3) and a post-study follow-up visit 4 - 8 days following administration of OCT461201 or placebo (i.e., Day 5 - 9). A dose leader design was implemented with 2 participants being dosed on the first dosing day (1 randomised to placebo, 1 to active drug) and the remainder of the cohort dosed at least 24 hours later pending an acceptable safety profile in the dose leader group. Safety and Pharmacokinetic data was reviewed by the Dose Escalation Review Committee before escalation to the next cohort/dose level.
Interventions
DRUGOCT461201 50 mg
Oral capsule
DRUGOCT461201 100 mg
Oral capsule
DRUGOCT461201 150 mg
Oral capsule
DRUGOCT461201 450 mg
Oral capsule
DRUGPlacebo
Placebo capsule
Sponsors
Simbec-Orion Group
Oxford Cannabinoid Technologies Holdings PLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind, randomised study
Intervention model description
Single ascending dose
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female participant, between 15 and 55 years of age inclusive at screening * Body mass index (BMI) of 18-30 kg/m2 * No clinically significant history of previous allergy/sensitivity to compounds similar to experimental drug or any of its excipients * No clinically significant results for serum biochemistry, haematology and/or urine analysis within 35 days before first dose of Investigational Medicinal Product (IMP) * No clinically significant abnormalities in 12-lead ECG within 35 days before dose of IMP * Available to complete the study including all follow up visits
Exclusion criteria
* Clinically significant history of gastrointestinal disorder likely to influence IMP absorption * Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction * Participation in a new chemical entity clinical study within the previous 3 months or 5 half-lives, whichever was longer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment Emergent Adverse Events during the study assessed as mild, moderate or severe | Day 1-9 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameter: Cmax | Day 1-3 | Maximum observed concentration |
| Pharmacokinetic parameter: AUC | Day 1-3 | Overall exposure |
| Pharmacokinetic parameter: t1/2 | Day 1-3 | Terminal elimination half life |
Countries
United Kingdom
Outcome results
None listed