None listed
Conditions
Brief summary
This is a Phase 1, open-label, randomised, 3-period, 2-sequence crossover study of paltusotine tablets with two different drug formulations in a total of approximately 20 healthy male and female participants. This study is evaluating 2 formulations of paltusotine. Paltusotine is being developed as a potential new treatment for Acromegaly and Carcinoid Syndrome. Participants will be assigned to one of two treatment sequences with a minimum 10-day washout between each Period. In each dosing period, enrolled participants will receive a single dose of the following treatments per their assigned treatment sequence. -Treatment A (Reference): Participants will receive a single dose of 60 mg paltusotine, administered as 2 × 30 mg tablets after an overnight fast with a 4-hour postdose fast -Treatment B (Test): Participants will receive a single dose of 60 mg paltusotine, administered as 1 × 60 mg tablet after an overnight fast with a 4-hour postdose fast. Blood samples will be collected at multiple timepoints to assess plasma concentrations and calculate PK parameters. Safety and tolerability will be monitored through adverse events, laboratory tests, vital signs, ECGs, and physical examinations.
Interventions
This is a Phase 1, single-dose, open-label, randomized, 3-period, 2-sequence, crossover study of paltusotine tablets with two different drug loads in healthy male and female participants.
A total of approximately 20 participants (approximately 10 males and 10 females) will be randomized to 1 of 2 treatment sequences (approximately 5 males and 5 females per sequence) as described below.
In each dosing period, enrolled participants will receive a single dose of the following treatments per their
This is a Phase 1, single-dose, open-label, randomized, 3-period, 2-sequence, crossover study of paltusotine tablets with two different drug loads in healthy male and female participants. A total of approximately 20 participants (approximately 10 males and 10 females) will be randomized to 1 of 2 treatment sequences (approximately 5 males and 5 females per sequence) as described below. In each dosing period, enrolled participants will receive a single dose of the following treatments per their assigned treatment sequence. - Treatment A (Control): Participants will receive a single dose of 60 mg paltusotine , administered as 2 × 30 mg tablets after an overnight fast with a 4-hour postdose fast. - Treatment B (Test): Participants will receive a single dose of 60 mg paltusotine, administered as 1 × 60 mg tablet after an overnight fast with a 4-hour postdose fast. All dosing will occur during in-patient confinement. Adherence to intervention will be monitored by study staff -Sequence A-B-A: Period 1 (Treatment A) followed by Period 2 (Treatment B) followed by Period 3 (Treatment A). There will be a minimum 10-day washout between each Period. -Sequence B-A-B: Period 1 (Treatment B) followed by Period 2 (Treatment A) followed by Period 3 (Treatment B). There will be a minimum 10-day washout between each Period. Participants will receive standardized meals for all meals during the in-patient period. In addition, the exact same standardized meal will be provided predose and postdose for all 3 periods. Participants will receive each dose with approximately 240 ml of water.
Sponsors
Crinetics Pharmaceuticals, Inc
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
-Male and female subjects 10 to 55 years of age -BMI 18 to 30kg/m2 -The participant is considered by the Principal Investigator (PI) to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings. -Willing to comply with fasting and liquid restriction requirements and consume protocol specified standardized meals -Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or must have her male partner agree to use agree to use of a condom combined with a highly effective method of contraception for duration of the study and until after 30 days after the last study dose. Females should also agree to not donate ova or oocytes for the duration of the study and until at least 30 days after the last dose of study drug. -Males must agree to use a condom when sexually active with a female partner of childbearing potential for the duration of the study and until at least 90 days after the last dose of study drug, or be surgically sterile, or agree to remain abstinent on a long-term and persistent basis. Males should also agree to not donate sperm for the duration of the study and until at least 90 days after the last dose of study drug.
Exclusion criteria
-Prior treatment with paltusotine -The participant has any uncontrolled or active major systemic disease which makes study participation unsafe or could interfere with evaluation of the endpoints of the study in the opinion of the PI -Active acute or chronic infection -The participant had an unstable psychological disorder or active suicidal ideation/behavior = within 1 year before Screening, based on the participant’s medical history and in the opinion of the PI. -The participant has a history of, or current, alcohol abuse and/or other drug addiction within 1 year prior to Screening, or a positive urine drug or breath alcohol at Screening or upon each admission -The participant had a blood loss or donated blood = greater than or equal to 500 mL within 30 days prior to admission or refuses to refrain from blood donation until 30 days after the last study dose (other than planned blood sampling for this study) -The participant was involved in an investigational medical device study or received any investigational drug within 30 days or 5 half-lives, whichever is longer prior to the first dosing of study drug. -Use of any prior prescribed medication without approval of the Investigator within 14 days or 5 half-lives whichever is longer prior to admission
Outcome results
None listed