Effect of ONC201 on Cardiac Repolarization in Healthy Participants - Part 1

A Randomized, Positive- and Placebo-Controlled Study to Evaluate the Effects of ONC201 on Cardiac Repolarization in Healthy Participants - Part 1

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12622001021763

Enrollment

Registered

2022-07-21

Start date

2022-11-08

Completion date

2022-11-30

Last updated

2023-08-21

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

Conditions

None listed

Brief summary

The purpose of part 1 of this study is to: • Evaluate how safe and well tolerated either a single 750mg dose or two 625mg doses of ONC201 is, in healthy participants. • To help determine the dose level and schedule for Part 2 of the ONC201-102 study Part 1 will enroll 6 participants to be randomized 1:1 to receive ONC201 750 mg, single dose (3 participants) or ONC201 administered as two 625 mg doses given 4 hours apart (3 participants). Participants will be housed in the clinic on Day -1 through to Day 3. Part 1 - will consist of a screening period of up to 28 days, in house period - Day -1 to Day 3 and a Follow up visit at Day 14 post dose.

Interventions

ONC201 (investigational drug) will be dosed, as a 125mg capsule orally, as per the following groups: Part 1 - 3 x Healthy Volunteers will be dosed once only with ONC201 750 mg (6 capsules) 3 x Healthy Volunteers will be dosed twice, 4 hours apart with ONC201 625mg (5 capsules) Adherence to intervention will be via mouth check of swallowed capsule both groups will occur simultaneously and will be run in parallel both being able to be dosed the same time

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

Male or female between 18 to 45 years of age Female must be of non-childbearing potential Body weight greater than 50 kg, body mass index between 18–30 kg/m2 Healthy Volunteers who are overtly healthy as determined by medical evaluation and judgment of the investigator including medical history, PE, laboratory tests, vital signs, and cardiac monitoring.

Exclusion criteria

Have a positive serological test result at the screening evaluation consistent with possible infection with HBV, HCV, or HIV. Have a positive pregnancy test at screening or Period 1 Day -1 Current history of moderate to heavy tobacco/nicotine use Abnormal 12-lead ECG at Screening or Period 1 Day -1, Resting supine heart rate less than 45 beats per minute or greater than 100 beats per minute Any clinically significant abnormal findings during physical examination or medical history

Outcome results