Effect of ONC201 on Cardiac Repolarization in Healthy Participants - Part 2

A Randomized, Positive- and Placebo-Controlled Study to Evaluate the Effects of ONC201 on Cardiac Repolarization in Healthy Participants - Part 2

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12622001020774

Enrollment

Registered

2022-07-21

Start date

2023-02-14

Completion date

2023-04-03

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 2 of this study is to: • Evaluate how safe and well tolerated ONC201 is, in healthy participants. • Evaluate the effects of ONC201 on cardiac repolarisation in healthy participants • Assess the effects of ONC201 on ECG (Electrocardiograms that measure the electrical activity of your heart) compared with moxifloxacin and placebo • Measure the body’s response to either a single 750 mg dose or two 625 mg doses of ONC201 This study will be conducted in two parts. Part 2 will enroll approx. 30 participants and each participant will receive each of (in a cross over design, with 7 days between treatments): A. Placebo (Negative Control) to match B. Moxifloxacin (Positive Control) 400 mg, single oral dose C. ONC201 (dose to be determined based on results of Part 1). For both parts participants will be housed in the clinic on Day -1 through to Day 3. Part 2 - will consist of a screening period of up to 28 days, 3 times in-house periods, Day -1 to Day 3, separated by at least 7 days, and a Follow up visit at Day 14 post last dose

Interventions

ONC201 (investigational drug) will be dosed, as a 125mg capsule orally Part 2: 30 x Healthy Volunteers will be dosed on 3 separate occasions (7 days apart) with each of ONC201 (dose to be determined from Part 1), Placebo and control treatment. Adherence to intervention will be via mouth check of swallowed capsule

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

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