None listed
Conditions
Brief summary
This study is an early-stage clinical trial to check whether a new medicine called PTC612 is safe for healthy adults to take. The study will also look at how the medicine moves through the body and whether eating food before taking it changes how the body absorbs it. Some participants will receive a single dose, others will receive the medicine for several days, and some will take it with or without food. Blood samples will be collected to measure the amount of medicine in the body and to look at substances related to inflammation. The study is based on the idea that PTC612 can be taken safely and may help reduce inflammation, supporting its future use in inflammatory diseases.
Interventions
Unique participants will be enrolled in each part and each cohort, part 2 of the study consists of two cohorts of eligible participants to evaluate food effects on the PTC612 tablet:
• Cohort 2A: tablet under fasted condition vs tablet under fed condition – standard meal
• Cohort 2B: tablet under fasted condition vs tablet under fed condition – high-fat high-calorie (HFHC) meal
Each cohort will use an open-label, randomized, 2-sequence, 2-period, 2-treatment, 2-way cross over design. Approxima
Unique participants will be enrolled in each part and each cohort, part 2 of the study consists of two cohorts of eligible participants to evaluate food effects on the PTC612 tablet: • Cohort 2A: tablet under fasted condition vs tablet under fed condition – standard meal • Cohort 2B: tablet under fasted condition vs tablet under fed condition – high-fat high-calorie (HFHC) meal Each cohort will use an open-label, randomized, 2-sequence, 2-period, 2-treatment, 2-way cross over design. Approximately 28 participants will be enrolled in Part 2. Cohorts 2A and 2B may begin in parallel once the next higher dose level in Part 1 (Single Ascending Dose) is well tolerated (ie, 30 mg). Within each cohort, participants will be randomized 1:1 to one of two treatment sequences (N=7 per sequence), as follows: Cohort 2A: • Sequence 1: Fasted (Period 1) and Fed with standard meal (Period 2) • Sequence 2: Fed with standard meal (Period 1) and Fasted (Period 2) Cohort 2B: • Sequence 1: Fasted (Period 1) and Fed with HFHC meal (Period 2) • Sequence 2: Fed with HFHC meal (Period 1) and Fasted (Period 2) Washout period between Sequences will be 2 weeks. Tablet fed (standard meal): Participants will receive a single 10 mg dose of PTC612 following an overnight fast of at least 10 hours, administered approximately 30 minutes after the start of a standard meal. Tablet fed (High Fat, High-Calorie meal): Participants will receive a single 10 mg dose of PTC612 following an overnight fast of at least 10 hours, administered approximately 30 minutes after the start of a high-fat,high-calorie (HFHC) meal. The meal must be completely consumed within 30 minutes, prior to dosing. No food is permitted for 4 hours post-dose. Water intake restrictions will be the same as those under the fasted condition. Composition of the Standard Meal - Total Calories: - 600-800kcal Calories from Protein: - 60-280kcal Calories From Carbohydrates:- 270-520kcal Calories From Fat: 210-280kcal High Fat, High Calorie Meal Total Calories: - 800-1000kcal Calories from Protein: - 150kcal Calories From Carbohydrates :- 250kcal Calories From Fat : 500-600kcal Participants will receive study drug directly from the Investigator (or designee), under medical supervision.
Sponsors
PTC Therapeutics, Inc.
Study design
Allocation
Randomised controlled 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. Participant must be between 18 to 65 years of age. 2. Be generally healthy, as determined by medical history, physical examination, blood and urine tests, heart test (ECG), and vital signs. 3. Body mass index BMI greater than 18.5 and less than or equal to 32.0 kilograms per square meter with a body weight of at least 50.0 kilograms for males or at least 45.0 kilograms for females at screening. 4. Have read, understood, and signed the informed consent form. 5. Be willing and able to attend all study visits and follow all study instructions and restrictions. 6. Be willing to stop most medications, supplements, and herbal products before the study, as required by the study doctor. 7. Be willing to avoid alcohol, nicotine products, caffeine, certain foods (including grapefruit and poppyseeds), and strenuous exercise for specified periods before and during the study. 8. Have negative screening tests for alcohol, drugs of abuse, and nicotine. 9. Women: •Must have negative pregnancy tests if able to become pregnant. •Must agree to use reliable contraception or abstain from sexual activity during the study and for a short time after the last dose. •Must not donate eggs during the study and shortly after. 10. Men: •Must agree to use barrier contraception if sexually active with women who could become pregnant. •Must not donate sperm during the study and for a period after the last dose. 11. For study parts requiring food before dosing, Participants must be willing and able to consume the entire high-fat high-calorie or standard meal in the designated timeframe.
Exclusion criteria
1. Have taken part in another clinical trial involving a drug or medical device within the last 30 days or plan to take part in another trial during this study. 2. Have any current or past medical or mental health condition that the study doctor believes could affect safety or interfere with study results. 3. Had a fever or symptoms of a viral or bacterial infection within 7 days before screening. 4. Have had cancer within the last 5 years, unless it was surgically removed and considered cured. 5. Have a history of severe allergic reactions or serious drug allergies. 6. Have any clinically significant abnormal findings at screening, including abnormal liver test results. 7. Have abnormal liver blood test results above accepted limits at screening. 8. Have a history of tuberculosis or a positive tuberculosis test at screening. 9. Have psychological or emotional conditions that may affect informed consent or ability to follow study requirements. 10. Are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study. 11. Have donated whole blood within the last 3 months, plasma within the last 2 weeks, or platelets within the last 6 weeks. 12. Have consumed alcohol within 48 hours before screening or study check in visits. 13. Have a history of alcohol abuse within the last 2 years. 14. Have evidence of active hepatitis B, hepatitis C, or human immunodeficiency virus infection at screening.
Outcome results
None listed