A Phase 1, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Paltusotine In Healthy Subjects
- Conditions
- Pituitary Gland disorder (acromegaly)acromegalyextreme growth and carcinoid syndrome1001469910052547
- Registration Number
- NL-OMON51860
- Lead Sponsor
- Crinetics Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 27
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the safety and tolerability of single doses of paltusotine starting<br /><br>at 80 mg up to a maximum of 240 mg</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate the PK of single doses of paltusotine</p><br>