NL-OMON49961撤回不适用
A Phase 1, Open-Label, Single Ascending Dose Study to Evaluate the Pharmacokinetics and Safety of Solriamfetol in Pediatric Subjects with Narcolepsy - JZP865-101
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 5
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
- 2 至 17（—）
入选标准
- •Each subject must meet the following criteria to be enrolled in the study.
- •1. Male and female subjects 6 to < 18 years old at Screening, depending on
- •2. Minimum body weight of 22 kg.
- •3. Subjects with diagnosis of narcolepsy according to International
- •Classification of Sleep Disorders-3 (ICSD-3) criteria, or, with the permission
- •of the medical monitor, completed a Multiple Sleep Latency Test (MSLT) during
- •Screening to confirm the diagnosis of narcolepsy by ICSD-3 criteria (ie, the
- •subject met all other ICSD-3 criteria for narcolepsy).
- •4. Subjects with documented written assent per institutional review board (IRB)
- •/ ethics committee (EC) requirements indicating that he/she is aware of the
- •investigational nature of the study and the required procedures and
- •restrictions before participation in any protocol-related activities.
- •5. Parent(s)/guardian(s) must give their written informed consent for
- •his/her/their child*s participation in the study.
- •6. Female subjects of childbearing potential (ie, fertile, following menarche)
- •and male subjects who have female partners of childbearing potential must agree
- •to use medically acceptable methods of contraception with their partners from
- •Screening, throughout the study, and for 30 days after the last dose of
- •solriamfetol. Medically acceptable methods of contraception that may be used by
- •the subject include abstinence (when this is in line with the preferred and
- •usual lifestyle of the subject), progestogen-only oral hormonal contraception,
- •where inhibition of ovulation is not the primary mode of action, and a
- •combination of a male condom with either cap, diaphragm, or sponge with
- •spermicide (double barrier methods). Periodic abstinence (calendar,
- •symptothermal, post-ovulation methods), withdrawal (coitus interruptus),
- •spermicides only, single barrier methods (male or female condom with or without
- •spermicide; cap, diaphragm, or sponge with spermicide), and lactational
- •amenorrhoea method (LAM) are not acceptable methods of contraception for this
- •study. Female condom and male condom should not be used together.
- •7. Subjects must agree to abstain from alcohol and nicotine-containing
- •products; including tobacco (eg, cigarettes, cigars, chewing tobacco, snuff),
- •e-cigarettes, and nicotine lozenge/gum/patch within 3 days prior to each dosing
- •in Periods 1, 2, and 3 through discharge from that period.
- •8. Subjects must agree to discontinue use of over-the-counter (OTC) or
- •prescription stimulants (eg, pseudoephedrine, methylphenidate, amphetamines,
- •modafinil, armodafinil, and pitolisant) the day before dosing and on each day
- •when receiving a dose of solriamfetol.
- •9. Subjects must have sufficient blood volume for PK sampling based on body
- •weight in accordance with applicable guidance (eg, European Commission*s
- •recommendations document *Ethical considerations for clinical trials on
- •medicinal products conducted with minors* 2017, or according to the IRB/EC
- •guidelines).
- •10. Subjects must be willing and able to comply with the study schedule, all
- •study procedures, and other requirements.
排除标准
- •Inclusion Criteria
- •Each subject must meet the following criteria to be enrolled in the study.
- •1. Male and female subjects 6 to < 18 years old at Screening, depending on
- •2. Minimum body weight of 22 kg.
- •3. Subjects with diagnosis of narcolepsy according to International
- •Classification of Sleep Disorders-3 (ICSD-3) criteria, or, with the permission
- •of the medical monitor, completed a Multiple Sleep Latency Test (MSLT) during
- •Screening to confirm the diagnosis of narcolepsy by ICSD-3 criteria (ie, the
- •subject met all other ICSD-3 criteria for narcolepsy).
- •4. Subjects with documented written assent per institutional review board (IRB)
- •/ ethics committee (EC) requirements indicating that he/she is aware of the
- •investigational nature of the study and the required procedures and
- •restrictions before participation in any protocol-related activities.
- •5. Parent(s)/guardian(s) must give their written informed consent for
- •his/her/their child*s participation in the study.
- •6. Female subjects of childbearing potential (ie, fertile, following menarche)
- •and male subjects who have female partners of childbearing potential must agree
- •to use medically acceptable methods of contraception with their partners from
- •Screening, throughout the study, and for 30 days after the last dose of
- •solriamfetol. Medically acceptable methods of contraception that may be used by
- •the subject include abstinence (when this is in line with the preferred and
- •usual lifestyle of the subject), progestogen-only oral hormonal contraception,
- •where inhibition of ovulation is not the primary mode of action, and a
- •combination of a male condom with either cap, diaphragm, or sponge with
- •spermicide (double barrier methods). Periodic abstinence (calendar,
- •symptothermal, post-ovulation methods), withdrawal (coitus interruptus),
- •spermicides only, single barrier methods (male or female condom with or without
- •spermicide; cap, diaphragm, or sponge with spermicide), and lactational
- •amenorrhoea method (LAM) are not acceptable methods of contraception for this
- •study. Female condom and male condom should not be used together.
- •7. Subjects must agree to abstain from alcohol and nicotine-containing
- •products; including tobacco (eg, cigarettes, cigars, chewing tobacco, snuff),
- •e-cigarettes, and nicotine lozenge/gum/patch within 3 days prior to each dosing
- •in Periods 1, 2, and 3 through discharge from that period.
- •8. Subjects must agree to discontinue use of over-the-counter (OTC) or
- •prescription stimulants (eg, pseudoephedrine, methylphenidate, amphetamines,
- •modafinil, armodafinil, and pitolisant) the day before dosing and on each day
- •when receiving a dose of solriamfetol.
- •9. Subjects must have sufficient blood volume for PK sampling based on body
- •weight in accordance with applicable guidance (eg, European Commission*s
- •recommendations document *Ethical considerations for clinical trials on
- •medicinal products conducted with minors* 2017, or according to the IRB/EC
- •guidelines).
- •10. Subjects must be willing and able to comply with the study schedule, all
- •study procedures, and other requirements.
- •Exclusion Criteria
- •Subjects who demonstrate any of the following will be excluded from the study.
- •1. Subjects with any significant abnormality in the physical or psychological
- •finding, or clinical laboratory results that could int
研究者
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