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

NCT00831077 | Completed Early Phase 1

• 1 other identifier: 3101001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

14C-ORM-14540

ACTIVE COMPARATOR

Drug: ORM-14540

14C-ORM-12741

ACTIVE COMPARATOR

Drug: ORM-12741

Interventions

ORM-14540 DRUG

i.v.

14C-ORM-14540

ORM-12741 DRUG

i.v.

14C-ORM-12741

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

CRST

Turku, Finland

Location

MeSH Terms

Interventions

ORM-12741

Study Officials

• Juha Peltonen, MD

  CRST

  PRINCIPAL INVESTIGATOR

• Virpi Mononen

  Orion Corporation, Orion Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: January 28, 2009
• Study Start: January 1, 2009
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: October 8, 2009

Record last verified: 2009-10

Locations

FI (1)