Pharmacokinetic Study of ORM-12741 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: ORM-12741

• Registration Number: NCT00818740
• Lead Sponsor: Orion Corporation, Orion Pharma

Brief Summary

The purpose of this study is to determine pharmacokinetic parameters of ORM-12741 in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-22
• Study Start: 2009-01
• Study First Submitted QC: 2009-01-07
• Study First Posted: 2009-01-08
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-07
• Last Update Posted: 2009-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ORM-12741 oral solution	ORM-12741	-
ORM-12741 oral capsule with food	ORM-12741	-
ORM-12741 oral capsule without food	ORM-12741	-
ORM-12741 i.v.	ORM-12741	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic variables including: Peak concentration in plasma (Cmax), Time to peak concentration in plasma (tmax), Area under the plasma concentration-time curve (AUC)	96 hours

Secondary Outcome Measures

Name	Time	Method
Safety variables including blood pressure (BP), heart rate (HR), electrocardiograms (ECGs), physical examination, laboratory safety variables (haematology, chemistry, serology and urinalysis) and adverse events (AEs).	throughout the study

Trial Locations

Locations (1)

CRST; 🇫🇮 Turku, Finland