Pituitary Gland disorder (acromegaly) acromegaly extreme growth and carcinoid syndrome
Conditions
Interventions
Group | Treatment | How often
1 | paltusotine 80 mg (oral solution of 40 mL) or placebo | once daily on Day 1
2 | paltusotine 160 mg (oral solution of 80 mL) or lower* or placebo | once
daily on Day
Sponsors
Crinetics Pharmaceuticals, Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Sex: male or female. 2. Age: 18 to 55 years, inclusive, date of signing informed consent. 3. Body mass index (BMI): 18.0 to 30.0 kg/m2, inclusive, date of signing informed consent. 4. Body weight: >=62.5 kg for Group 3 only. 5. Status: healthy subjects. 6. At screening, female subjects may be of childbearing potential but not pregnant or lactating, or they may be of nonchildbearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1 year postmenopausal [amenorrhea duration of 12 consecutive months]); nonpregnancy will be confirmed for all female subjects by a negative serum pregnancy test conducted at screening, admission to the clinical research center, and at the follow-up visit, 7. Female subjects of childbearing potential who have a fertile male sexual partner must agree to use adequate contraception from at least 12 weeks prior to administration of the study drug until 90 days after the follow up visit. Adequate contraception is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm, a cervical cap, or a condom. Total abstinence from heterosexual intercourse, in accordance with the lifestyle of the subject, is also acceptable. 8. Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from admission to the clinical research center until 90 days after the follow-up visit. Adequate contraception for the male subject (and his female partner, if she is of childbearing potential) is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm, a cervical cap, or a condom. Total abstinence, in accordance with the lifestyle of the subject, is also acceptable. 9. All prescribed medication must have been stopped at least 30 days prior to admission to the clinical research center. An exception is made for hormonal contraceptives, which may be used throughout the study. Another exception is made for SARS-CoV-2 vaccines, which are allowed up to 2 weeks prior to admission to the clinical research center. 10. All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John*s wort) must have been stopped at least 30 days prior to admission to the clinical research center. An exception is made for paracetamol, which is allowed up to admission to the clinical research center. Further criteria apply, see protocol.
Exclusion criteria
Exclusion criteria: 1. Employee of PRA or the Sponsor. 2. History of relevant drug and/or food allergies. 3. Smoking more than 5 cigarettes, 1 cigar, or 1 pipe daily; the use of tobacco products in the 48 hours (2 days) prior to admission to the clinical research center is not allowed. 4. History of alcohol abuse or drug addiction (including soft drugs like cannabis products) in the last year. 5. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening and admission to the clinical research center. 6. Average intake of more than 21 units of alcohol per week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits). 7. Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) 1 and 2 antibodies. Subjects with previous hepatitis C infection that is now cured may be eligible. 8. Participation in a drug study within 30 days prior to drug administration in the current study. Participation in 4 or more other drug studies in the 12 months prior to drug administration in the current study. 9. Participation in any previous clinical study with paltusotine. 10. History of hypersensitivity reactions to any excipients in the study drug. Further criteria apply, see protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of single doses of paltusotine starting at 80 mg up to a maximum of 240 mg | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the PK of single doses of paltusotine | — |
Countries
Netherlands
Outcome results
None listed