A Phase-1 Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 in Healthy Volunteers
Status and phase
Completed
Phase 1
Conditions
Healthy
Treatments
Drug: AVP-923
Drug: AVP-786
Details and patient eligibility
About
To assess the multiple-dose pharmacokinetics (PK), safety and tolerability of AVP-786 (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) in healthy volunteers.
Enrollment
56 patients
Sex
Male
Ages
18 to 45 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- Healthy adult males
- 18 - 45 years of age
- BMI 18 - 30 kg/m2
Exclusion criteria
- History or presence of significant disease
- History of substance abuse and/or alcohol abuse with the past 3 years
- Use of tobacco-containing or nicotine-containing products within 6 months
- Use of any prescription or the over-the-counter medications within 14 days
Trial design
56 participants in 6 patient groups
Cohort A - Period 1
Experimental group
Description:
Twice daily dosing orally for 7 days
Treatment:
Drug: AVP-786
Cohort A - Period 2
Active Comparator group
Description:
Twice daily dosing orally for 7 days
Treatment:
Drug: AVP-923
Cohort A - Period 3
Experimental group
Description:
Twice daily dosing orally for 7 days
Treatment:
Drug: AVP-786
Cohort B - Period 1
Experimental group
Description:
Twice daily dosing orally for 7 days
Treatment:
Drug: AVP-786
Cohort B - Period 2
Active Comparator group
Description:
Twice daily dosing orally for 7 days
Treatment:
Drug: AVP-923
Cohort B - Period 3
Experimental group
Description:
Twice daily dosing orally for 7 days
Treatment:
Drug: AVP-786
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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