None listed
Conditions
Brief summary
This will be a phase 1, first-in-human, open-label, 3-period, 3-treatment crossover design study to evaluate the food effects and relative bioavailability of 2 formulations of PTC607 in 8 healthy participants.
Interventions
This study in an open-label, fixed sequence, 3 period crossover relative bioavailability study of 2 different formulations followed by a food effect assessment of PTC607 in 8 healthy participants. The dose of PTC607 will be determined based on at least the data from Cohort 1.1 and Cohort 1.2 from ACTRN12622001534774 study. The periods will be separated by a minimum of 5 half-lives (approximately 110 hours).
In Period 1, the suspension formulation of PTC607 will be orally administered after an ov
This study in an open-label, fixed sequence, 3 period crossover relative bioavailability study of 2 different formulations followed by a food effect assessment of PTC607 in 8 healthy participants. The dose of PTC607 will be determined based on at least the data from Cohort 1.1 and Cohort 1.2 from ACTRN12622001534774 study. The periods will be separated by a minimum of 5 half-lives (approximately 110 hours). In Period 1, the suspension formulation of PTC607 will be orally administered after an overnight fast of at least 10 hours. Participants will remain fasted until 4 hours post dose. In Period 2, the tablet dose of PTC607 will be administered after an overnight fast of at least 10 hours. Participants will remain fasted until 4 hours post dose. In Period 3, the final tablet dose of PTC607 will be administered after participants have consumed a high fat meal. PTC607 will be administered 30 minutes after the start of the assigned breakfast. At least 90% of the meal must be consumed within 30 minutes of beginning. The standardised meal will be the standard US Food and Drug Administration high-fat, high calorie (800 to 1000 calories) breakfast. Approximately 50% of total caloric content of the meal will be from fat. The meal will derive approximately 150, 250, and 500-600 calories from protein, carbohydrate, and fat, respectively. Healthy volunteers will stay in the clinical research unit for the entire duration of dosing and will take study drug under direct supervision of the clinical research unit staff .
Sponsors
CTI Clinical Trial and Consulting Services Australia Pty Ltd.
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males and females aged 18 to 65 years inclusive at Screening 2. Participants able to provide informed consent 3. Body mass index of greater than or equal to 18.5 and less than or equal to 30.0 kg/m2 with a body weight of greater than or equal to 50.0 kg for male participants and a body weight of greater than or equal to 45.0 kg for female participants at Screening 4. Generally healthy as determined by the investigator based on medical evaluation, including medical history, physical examination, laboratory test results, ECG, and vital signs. 5. Male participants must be willing to use 2 acceptable contraceptive methods for the duration of the study and for a minimum of 6 months after the last dose, and female participants of childbearing potential must be willing to use 2 acceptable contraceptive methods for the duration of the study and for a minimum of 30 days after the last dose. 6. All female participants of childbearing potential must have a negative serum pregnancy test result at Screening and a negative urine pregnancy test on Day -1. 7. Male participants must agree to not donate sperm for the duration of the study and for at least 6 months after the last dose. 8. Participants must be willing and able to consume the entire high-fat breakfast in the designated timeframe. Participants with allergies or with vegetarian or vegan lifestyle choices that would prevent them from eating these breakfasts will be excluded.
Exclusion criteria
1. Participants that participated in any drug or device clinical investigation within 60 days prior to Screening or who anticipate participating in any drug or device clinical investigation within the duration of this study. 2. Prior or ongoing medical condition (eg, concomitant illness, psychiatric condition), medical history, and/or physical findings that, in the investigator’s opinion, could adversely affect the safety of the participant or could impair the assessment of study results. 3. An abnormal general neurological examination. 4. Presence of any clinically significant abnormality during Screening. 5. Any psychological or emotional problems, any disorders, or resultant therapy that is likely to invalidate informed consent or limit the ability of the participant to comply with the protocol requirements. 6. A positive hepatitis B surface antigen, positive hepatitis C antibody, or HIV antibody result at Screening. 7. Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at Screening or menses) of 50 to 499 mL within 30 days or more than 499 mL within 56 days prior to dosing. 8. Excessive alcohol consumption (regular alcohol intake greater than or equal to 21 units per week for male participants and greater than or equal to 14 units per week for female participants) within 6 months prior to Screening. One unit (8 g) is equivalent to a half pint (280 mL) of beer, 1 measure (25 mL) of spirits, or 1 small glass (125 mL) of wine. 9. The participant is a smoker or uses other nicotine-containing products. Ex-smokers must have ceased smoking >3 months prior to Screening. Smokers who consume <4 tobacco products per week are allowed. 10. The participant has consumed grapefruit (or its juice), star fruit, pomegranate, pomelo, tangelo, or Seville orange-containing products in the 1 week before Screening. 11. A positive urine drug screen, cotinine screen, or alcohol breath test at Screening or on Day -1 of each treatment period. 12. Females who are pregnant or nursing. 13. Participant has previously received PTC607.
Outcome results
None listed