Single Ascending Oral Dose Study to Investigate the Effects of OCT461201 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-26

Study Completion Date

2023-09-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Single ascending dose

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-blind, randomised study

Study Groups

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OCT461201 Dose Level 1

Single ascending dose of OCT461201 10 mg

Group Type EXPERIMENTAL

OCT461201 50 mg

Intervention Type DRUG

Oral capsule

Placebo

Intervention Type DRUG

Placebo capsule

OCT461201 Dose Level 2

Single ascending dose of OCT461201 50 mg

Group Type EXPERIMENTAL

OCT461201 100 mg

Intervention Type DRUG

Oral capsule

Placebo

Intervention Type DRUG

Placebo capsule

OCT461201 Dose Level 3

Single ascending dose of OCT461201 150 mg

Group Type EXPERIMENTAL

OCT461201 150 mg

Intervention Type DRUG

Oral capsule

Placebo

Intervention Type DRUG

Placebo capsule

OCT461201 Dose Level 4

Single ascending dose of OCT461201 450 mg

Group Type EXPERIMENTAL

OCT461201 450 mg

Intervention Type DRUG

Oral capsule

Placebo

Intervention Type DRUG

Placebo capsule

Placebo

Single dose of matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsule

Interventions

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OCT461201 50 mg

Oral capsule

Intervention Type DRUG

OCT461201 100 mg

Oral capsule

Intervention Type DRUG

OCT461201 150 mg

Oral capsule

Intervention Type DRUG

OCT461201 450 mg

Oral capsule

Intervention Type DRUG

Placebo

Placebo capsule

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes