NL-OMON51860已完成不适用
A Phase 1, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Paltusotine In Healthy Subjects - Paltusotine single ascending dose safety and PK study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •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.
排除标准
- •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.
研究者
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