Status:
COMPLETED
Study to Assess the Bioavailability, Pharmacokinetics, Safety, and Tolerability of AVP-923 in Healthy Adult Participants
Lead Sponsor:
Avanir Pharmaceuticals
Conditions:
Healthy Adult Male and Female Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study will be conducted to evaluate the relative bioavailability, pharmacokinetics, safety, and tolerability of AVP-923 (dextromethorphan hydrobromide \[DM\] and quinidine sulfate \[Q\] capsules)...
Detailed Description
This is an open-label, single-center, randomized, single-dose, 3-treatment, 3-period, 6-sequence crossover study in healthy adult participants consisting of approximately 7 weeks of treatment. The stu...
Eligibility Criteria
Inclusion
- Healthy adults, 18 to 65 years of age, inclusive
- Willing to sign informed consent form
- Cytochrome P450 2D6 genotype that confers extensive metabolizer profile (as per documented phenotype interpretation from local laboratory and approval from Avanir)
Exclusion
- History or presence of significant pulmonary, hepatic, renal, hematologic, allergic, endocrine (including diabetes), immunologic, dermatologic, neurologic (including history or presence of seizures or convulsive disorders), psychiatric disease (including history of suicidal ideation or behavior) or any eating disorder deemed clinically significant by the investigator
- History or presence of significant cardiovascular disease, including complete heart block, QT interval corrected for heart rate (QTc) prolongation, and/or torsades de pointes
- History or presence of any gastrointestinal (GI) disease or condition that could compromise participant safety or affect the absorption of study drug, including GI ulcers, GI bleeding, esophageal or gastric varices, and dyspepsia requiring regular (i.e., more frequently than once a month) use of acid-reducing drugs
- Known hypersensitivity/intolerance to dextromethorphan or quinidine
- Participants whom the principal investigator or his delegate deems to be ineligible
Key Trial Info
Start Date :
November 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2018
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03381664
Start Date
November 28 2017
End Date
January 30 2018
Last Update
February 23 2018
Active Locations (1)
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1
Vince & Associates Clinical Research
Overland Park, Kansas, United States, 66212