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Pharmacokinetics (PK) and Tolerability of AVP-786 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01787747
Recruitment Status : Completed
First Posted : February 11, 2013
Last Update Posted : June 26, 2014
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals

Brief Summary:
To assess the single- and multiple-dose pharmacokinetic (PK), safety and tolerability of AVP-786 in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: AVP-786 Dose 1 Drug: AVP-786 Dose 2 Drug: AVP-786 Dose 1/Q Dose 1 Drug: AVP-786 Dose 1/Q Dose 2 Drug: AVP-786 Dose 2/Q Dose 2 Drug: AVP-923 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: A Phase 1, Single-center, Randomized, Double-blind, Study to Assess the Pharmacokinetics, Safety and Tolerability of Single and Multiple Doses of AVP-786 (Deuterated Dextromethorphan) in Healthy Volunteers
Study Start Date : October 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohorts A and C
Single dose (D1) followed by twice daily dosing for 7 days
Drug: AVP-786 Dose 1
Drug: AVP-923
Experimental: Cohorts B and D
Single dose (D1) followed by twice daily dosing for 7 days
Drug: AVP-786 Dose 2
Drug: AVP-923
Experimental: Cohorts E and F
Single dose (D1) followed by twice daily dosing for 7 days
Drug: AVP-786 Dose 1/Q Dose 1
Drug: AVP-923
Experimental: Cohorts G and I
Single dose (D1) followed by twice daily dosing for 7 days
Drug: AVP-786 Dose 1/Q Dose 2
Drug: AVP-923
Experimental: Cohorts H and J
Single dose (D1) followed by twice daily dosing for 7 days
Drug: AVP-786 Dose 2/Q Dose 2
Drug: AVP-923



Primary Outcome Measures :
  1. Plasma concentrations of parent and metabolites [ Time Frame: 8 Days ]

Secondary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 8 days ]
    Assessments to include Physical Examination (PE), Labs, ECGs, and Adverse Events (AEs)



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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 and/or alcohol abuse within the past 3 years
  • Use of tobacco-containing or nicotine-contining products within 6 months
  • Use of any prescription of over-the-counter (OTC) medication within 14 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01787747


Locations
Australia, South Australia
CMAX
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
Avanir Pharmaceuticals
Investigators
Principal Investigator: Sepehr Shakib, MD CMAX

Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01787747     History of Changes
Other Study ID Numbers: 12-AVR-132
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014

Keywords provided by Avanir Pharmaceuticals:
Pharmacokinetics
Healthy Volunteers
dextromethorphan with quinidine
deuterated dextromethorphan

Additional relevant MeSH terms:
Dextromethorphan
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs