NCT06398925

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jul 2023

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 3, 2024

Completed
Last Updated

May 3, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

April 23, 2024

Last Update Submit

April 30, 2024

Conditions

Healthy

Keywords

Phase 1Single Ascending DoseHealth volunteer

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Treatment Emergent Adverse Events during the study assessed as mild, moderate or severe

    Day 1-9

Secondary Outcomes (3)

  • Pharmacokinetic parameter: Cmax

    Day 1-3

  • Pharmacokinetic parameter: AUC

    Day 1-3

  • Pharmacokinetic parameter: t1/2

    Day 1-3

Study Arms (5)

OCT461201 Dose Level 1

EXPERIMENTAL

Single ascending dose of OCT461201 10 mg

Drug: OCT461201 50 mgDrug: Placebo

OCT461201 Dose Level 2

EXPERIMENTAL

Single ascending dose of OCT461201 50 mg

Drug: OCT461201 100 mgDrug: Placebo

OCT461201 Dose Level 3

EXPERIMENTAL

Single ascending dose of OCT461201 150 mg

Drug: OCT461201 150 mgDrug: Placebo

OCT461201 Dose Level 4

EXPERIMENTAL

Single ascending dose of OCT461201 450 mg

Drug: OCT461201 450 mgDrug: Placebo

Placebo

PLACEBO COMPARATOR

Single dose of matching placebo

Drug: Placebo

Interventions

OCT461201 50 mgDRUG

Oral capsule

OCT461201 Dose Level 1
OCT461201 100 mgDRUG

Oral capsule

OCT461201 Dose Level 2
OCT461201 150 mgDRUG

Oral capsule

OCT461201 Dose Level 3
OCT461201 450 mgDRUG

Oral capsule

OCT461201 Dose Level 4
PlaceboDRUG

Placebo capsule

OCT461201 Dose Level 1OCT461201 Dose Level 2OCT461201 Dose Level 3OCT461201 Dose Level 4Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Simbec-Orion

Merthyr Tydfil, CF48 4DR, United Kingdom

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blind, randomised study
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Single ascending dose
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2024

First Posted

May 3, 2024

Study Start

July 26, 2023

Primary Completion

September 25, 2023

Study Completion

September 25, 2023

Last Updated

May 3, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)