Narcolepsy With or Without CataplexyPhase 1NCT01093508
Single-dose Safety Study of APD916 in Healthy Volunteers
A Phase 1 study testing APD916 in people with Narcolepsy With or Without Cataplexy, run by Arena Pharmaceuticals at 1 site in United States.
Trial summary
The APD916-001 study is designed primarily to evaluate the safety and tolerability of APD916 when administered as a single dose Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Narcolepsy With or Without Cataplexy
- What is being tested?
- APD916
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jul 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or females ages 18-45 years
- Body weight of 50-100 kg (110-220 pounds)
- Eligible female subjects will be non-pregnant, evidenced by a negative serum pregnancy test at Screening and a urine dipstick pregnancy test on Day -1 (Check-In); non-lactating; surgically sterile, postmenopausal, or agree to continue to use a medically accepted method of birth control during and for at least 1 month after last study medication administration.
- Eligible male subjects will either be surgically sterile (i.e., vasectomy), for at least 3 months prior to screening, or agree to use a condom with spermicide when sexually active with a female partner who is not using an acceptable method of birth control during the study and for 1 month after.
Who cannot join
- Subject who has donated any blood, or had significant blood loss within 56 days of dosing
- History of smoking or tobacco use within 3 months prior to dosing
- History of epilepsy or other seizure disorder
- Recent history (within 2 years prior to the screening visit) of sleep disorders
- History (within 2 years prior to the screening visit) of ADD or ADHD
- Traveled across more than 3 time zones within 2 weeks prior to dosing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study to Assess the Tolerability and Pharmacokinetics of APD916 Administered to Healthy Adult Subjects
The APD916-001 study is designed primarily to evaluate the safety and tolerability of APD916 when administered as a single dose
Read the detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, single-dose escalation study of up to 9 dose cohorts (1, 2, 5, 10, 20, 30, 45, 70 and 90 mg) each comprising 8 subjects (2 to receive placebo, 6 to receive APD916). Each cohort will be assigned to receive a single dose of APD916. After dosing within the first cohort has been completed and safety data review identifies no tolerability issues, and the principal investigator (PI) and Sponsor have agreed that it is safe to proceed, then subjects in the next cohort may be dosed.
- Conditions
- Narcolepsy With or Without Cataplexy
- Being tested
- APD916
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APD916Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of single, escalating doses of APD916 when administered to healthy adult subjects
Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters.
Measured: Single dose
Secondary outcomes (1)
To assess the pharmacokinetic properties of single, escalating doses of APD916
Pharmacokinetic samples (blood and urine) will be collected.
Measured: Single dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Narcolepsy With or Without CataplexyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arena Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James Maynard, MD, Principal investigator, Community Research, Cincinnati, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093508
- Sponsor's protocol ID
- APD916-001
- Status last verified
- Nov 2010
- First submitted
- 24 Mar 2010
- Last updated
- 2 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study to Assess the Tolerability and Pharmacokinetics of APD916 Administered to Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01093508
- Acronym / sponsor ID
- APD916-001
- Conditions
- Narcolepsy With or Without Cataplexy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Arena PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 26 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The APD916-001 study is designed primarily to evaluate the safety and tolerability of APD916 when administered as a single dose
Detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, single-dose escalation study of up to 9 dose cohorts (1, 2, 5, 10, 20, 30, 45, 70 and 90 mg) each comprising 8 subjects (2 to receive placebo, 6 to receive APD916). Each cohort will be assigned to receive a single dose of APD916. After dosing within the first cohort has been completed and safety data review identifies no tolerability issues, and the principal investigator (PI) and Sponsor have agreed that it is safe to proceed, then subjects in the next cohort may be dosed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males or females ages 18-45 years
- Body weight of 50-100 kg (110-220 pounds)
- Eligible female subjects will be non-pregnant, evidenced by a negative serum pregnancy test at Screening and a urine dipstick pregnancy test on Day -1 (Check-In); non-lactating; surgically sterile, postmenopausal, or agree to continue to use a medically accepted method of birth control during and for at least 1 month after last study medication administration.
- Eligible male subjects will either be surgically sterile (i.e., vasectomy), for at least 3 months prior to screening, or agree to use a condom with spermicide when sexually active with a female partner who is not using an acceptable method of birth control during the study and for 1 month after.
Key exclusion criteria (6 listed)
- Subject who has donated any blood, or had significant blood loss within 56 days of dosing
- History of smoking or tobacco use within 3 months prior to dosing
- History of epilepsy or other seizure disorder
- Recent history (within 2 years prior to the screening visit) of sleep disorders
- History (within 2 years prior to the screening visit) of ADD or ADHD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APD916 | Drug | – |
Primary outcome
To evaluate the safety and tolerability of single, escalating doses of APD916 when administered to healthy adult subjects
Time frame: Single dose
Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters.
1 secondary outcome
To assess the pharmacokinetic properties of single, escalating doses of APD916
Time frame: Single dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2010.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Maynard, MD principal investigator
Community Research, Cincinnati, OH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing APD916 in people with Narcolepsy With or Without Cataplexy, run by Arena Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of single, escalating doses of APD916 when administered to healthy adult subjects (time frame: Single dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2010.