CompletedPhase 1

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

Australia48 participantsStarted 2012-10-01

Plain-language summary

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

Who can participate

Age range18 Years – 45 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Plasma concentrations of parent and metabolites

Timeframe: 8 Days

Trial details

NCT IDNCT01787747

SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-02-01

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