Single-dose Safety Study of APD916 in Healthy Volunteers
Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study to Assess the Tolerability and Pharmacokinetics of APD916 Administered to Healthy Adult Subjects
1 other identifier
interventional
72
1 country
1
Brief Summary
The APD916-001 study is designed primarily to evaluate the safety and tolerability of APD916 when administered as a single dose
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 24, 2010
CompletedFirst Posted
Study publicly available on registry
March 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedNovember 2, 2010
November 1, 2010
1 month
March 24, 2010
November 1, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Single dose
Secondary Outcomes (1)
To assess the pharmacokinetic properties of single, escalating doses of APD916
Single dose
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Community Research
Cincinnati, Ohio, 45255, United States
Related Links
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
James Maynard, MD
Community Research, Cincinnati, OH
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 24, 2010
First Posted
March 26, 2010
Study Start
March 1, 2010
Primary Completion
April 1, 2010
Study Completion
July 1, 2010
Last Updated
November 2, 2010
Record last verified: 2010-11