A Phase 1, Open-Label, Single Ascending Dose Study to Evaluate the Pharmacokinetics and Safety of Solriamfetol in Pediatric Subjects with Narcolepsy
- Conditions
- Excessive daytime sleepiness10040998
- Registration Number
- NL-OMON49961
- Lead Sponsor
- Jazz Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 5
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
Group.
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.
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
Group.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>PRIMARY OBJECTIVE To characterize the pharmacokinetics (PK) of single doses of<br /><br>solriamfetol<br /><br>in pediatric subjects with narcolepsy.</p><br>
- Secondary Outcome Measures
Name Time Method <p>SECONDARY OBJECTIVE To assess the safety and tolerability of single doses of<br /><br>solriamfetol in<br /><br>pediatric subjects with narcolepsy.</p><br>