Investigating the safety and tolerability of ONC201 in healthy adults under fasting and fed conditions - Part 2b

INTERVENTION: Participants will randomly receive each of the following single‐dose treatments over the course of 2 treatment periods with a washout interval between doses of at least 7 days: • Treatment A: Single 625 mg dose of ONC201 administered as five 125 mg capsules under a fasting condition (nothing but water for at least 10 hours). • Treatment B: Single 625 mg dose of ONC201 administered as five 125 mg capsules within 10 mins after consumption (in entirety) of a standardized high‐fat meal (800‐1000 total calories). All single doses will be administered in the clinic and a mouth check to confirm compliance will occur. Allocation to sequence of treatment periods will occur based on a randomisation list. The standardized meal is a high fat content breakfast that has approximately 50% of calories from fat and is a total of approximately 800‐1000 calories (fat and non‐fat). CONDITION: Cancer ‐ Brain Cancer; ; Cancer PRIMARY OUTCOME: To investigate the safety and tolerability ( by review of clinical and laboratory safety parameters including: AEs, absolute and changes over time of hematology, clinical chemistry, vital signs, and ECG intervals) following single doses of ONC201 administered orally in healthy adults in all parts of the study; Adverse events: assessed in accordance with the Common Terminology Criteria for Adverse Events (CTCAE5.0); heart rate assessed using radial pulse; haematology/Biochemistry assessed using a blood sample; ECG parameters (PR, QRS, QT, and QTc intervals) assessed by review of ECG print out.; Neurological (Neurological Assessment in Neuro‐Oncology (NANO) scale) and physical examinations assessed for changes. [laboratory safety parameters taken on screening, on Days ‐1, 3, and 7 post dose in each treatment period, and at the Follow Up (FU) ‐ 14 days after last dose/Withdrawal (WD) visit; Adverse events (AEs) reviewed continually throughout the trial,; Vital signs ‐ (blood pressure, respiratory rate, pulse rate, and temperature) will be measured at screening, on Days ‐1, 1, and 3 post dose in each treatment period, and at the FU ‐ 14 days after last dose/WD visit, On Day 1 in each treatment period, measurements will be taken predose (3 replicates at 1‐minute intervals, performed 1 hour prior to dosing) and at approximately 3 hours post dose.; ECG‐ will be performed at screening, on Day 1 and 3 post dose in each treatment period, and at the FU ‐ 14 days after last dose/WD visit. On Day 1, ECGs will be obtained predose and at approximately 2, 4, 8, and 24 hours post dose; ] SECONDARY OUTCOME: To characterize plasma ONC201 Cmax, Tmax, AUClast, AUCinf, %AUCextrap, t1/2, CL/F, Vz/F following single escalating doses of ONC201 administered orally in healthy adults [Blood samples will be taken predose (within 15 minutes prior to dosing) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, and 168 hours post dose.] INCLUSION CRITERIA: 1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions in this protocol. 2. Male or female between 18 to 55 years of age. 3. Female must be of non‐childbearing potential i.e., postmenopausal woman or a premenopausal woman documented as surgically sterile following either a hysterectomy and/or bilateral oophorectomy, tubal ligation or placement of bilateral fallopian tube occlusion, or with medically documented ovarian failure. 5. Males must agree to refrain from sperm donation during the study and for at least 90 days after study drug administration. 6. Body mass index from 18 to 32 kg/m2, inclusive. 7. Participants who are overtly healthy as determined by medical evaluation and j 4. Males must be surgically sterilized OR must agree to use an acceptable method(s) of contraception during heterosexual intercourse with a female partner capable of becoming pregnant while enrolled in the study