Early Phase I Microdosing Study of ORM-14540 and ORM-12741

Sponsor

Orion Corporation, Orion Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT00831077

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine pharmacokinetic parameters of ORM-12741 and ORM-14540 in healthy volunteers.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: ORM-14540 Drug: ORM-12741	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Pharmacokinetic Properties of ORM-14540 and ORM-12741 After Administration of a Microdose of 14C-labelled Drug; An Open, Non-randomised, Single Dose, Single Centre Study in Healthy Male Subjects

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Apr 1, 2009

Actual Study Completion Date :

Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 14C-ORM-14540	Drug: ORM-14540 i.v.
Active Comparator: 14C-ORM-12741	Drug: ORM-12741 i.v.

Arm

Intervention/Treatment

Active Comparator: 14C-ORM-14540

Drug: ORM-14540

i.v.

Active Comparator: 14C-ORM-12741

Drug: ORM-12741

i.v.

Outcome Measures

Primary Outcome Measures

Pharmacokinetic variables including: Area under the concentration-time curve (AUC), Maximum observed concentration (Cmax) at the end of infusion, Terminal elimination half-life (t½z), Total clearance (CL) [72 hours]

Secondary Outcome Measures

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). [Before and after study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Written informed consent (IC) obtained.
Good general health ascertained by detailed medical history and physical examinations.
Males between 18 and 45 years (inclusive).
Body Mass Index (BMI) between 18-30 kg/m2 (inclusive, BMI = weight/height2).
Weight 55-100 kg (inclusive).

Exclusion Criteria:

A predictable poor compliance or inability to communicate well with the investigator or study centre personnel.
Veins unsuitable for repeated venipuncture
Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric diseases as judged by the investigator.
Any condition requiring regular concomitant medication including herbal products or likely to need any concomitant treatment during the study.
Susceptibility to severe allergic reactions.
Intake of any medication that could affect the outcome of the study, within 2 weeks prior to the first study treatment or less than 5 times a half-life of the medication. Possible enzyme inducing drugs will be discussed case-by-case with the sponsor.
Regular consumption of more than 21 units of alcohol per week (1 unit = 4 cl spirits, about 13 g of alcohol).
Current use of nicotine-containing products more than 5 cigarettes or equivalent/day.
Inability to refrain from using nicotine-containing products during the stay at the study centre.
Inability to refrain from consuming caffeine-containing beverages during the stay in the study centre, e.g. propensity in getting headache when refraining from caffeine-containing beverages.
Blood donation or loss of significant amount of blood within 2 months prior to the screening visit.
Abnormal 12-lead electrocardiogram (ECG) finding of clinical relevance in supine position after resting for 10 minutes at the screening visit, for example:- QTc (calculated through the Bazett's formula) > 450msec,- PR < 120 msec or > 210 msec,- QRS < 70 msec or > 120 msec.
Heart rate (HR) < 45 beats/minute or > 100 beats/minute in supine position after resting for 10 minutes at the screening visit.
At the screening visit, systolic blood pressure (BP) < 90 mmHg or > 140 mmHg in supine position after resting for 10 minutes, diastolic BP < 50 mmHg or > 90 mmHg in supine position after resting for 10 minutes.
Any abnormal value of laboratory, vital signs, or physical examination, which may in the opinion of the investigator interfere with the interpretation of the test results or cause a health risk for the subject if he takes part into the study.
History of drug abuse or positive result in drug abuse test.
Positive serology to human immunodeficiency virus antigen/antibodies (HIVAgAb), hepatitis C virus antibodies (HCVAb) or hepatitis B surface antigen (HBsAg).
Any other condition that in the opinion of the investigator would interfere with the evaluation of the results or constitute a health risk for the subject.
Participation in a clinical drug study within 3 months prior to the screening visit in this study, or earlier participation in a clinical study with ORM-12741.
Exposure to 14C-labelled drugs or diagnostics within 12 months prior to the screening visit.
Men who are not practising clinically accepted method of contraception during the study and next 3 months after the study treatment administration.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CRST	Turku		Finland

Sponsors and Collaborators

Orion Corporation, Orion Pharma

Investigators

Principal Investigator: Juha Peltonen, MD, CRST
Study Director: Virpi Mononen, Orion Corporation, Orion Pharma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00831077

Other Study ID Numbers:

3101001

First Posted:

Jan 28, 2009

Last Update Posted:

Oct 8, 2009

Last Verified:

Oct 1, 2009

Keywords provided by , ,

Healthy volunteers

Study Results

No Results Posted as of Oct 8, 2009