Excretion Balance and Metabolism After a Single Oral Dose of 14C-Labelled ORM-12741

NCT00817544 | Completed Phase 1

• 1 other identifier: 3098004
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The study is conducted to examine absorption of C14-ORM-12741 from intestine to bloodstream, distribution to bloodstream, metabolism in the liver and excretion of the parent drug and metabolites to faeces, urine and expired air

Conditions

Healthy Male Volunteers

Keywords

3098004; Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• The excretion balance of total 14C-radioactivity after a single oral dose of 14C-ORM-12741

  Total 14C-radioactivity in faeces and urine until pre-defined criteria are met. The total duration of the study will be approximately 5 - 6 weeks for each subject.

Secondary Outcomes (1)

• To gain further information on the safety of ORM-12741

  2 months

Study Arms (1)

ORM-12741

EXPERIMENTAL

ORM-12741

Drug: ORM-12741

Interventions

ORM-12741 DRUG

3 mg of ORM-12741 as a single dose. Contains 0.73 mg (2.5 MBq) 14C labelled ORM-12741

Also known as: healthy volunteer

ORM-12741

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Gender male
• Age 18-60 years, inclusive
• Weight 55-100 kg, inclusive
• Body mass index (BMI) 18.0 - 30.0 kg/m2 (inclusive)
• Ability and willingness to abstain from alcohol, tobacco products, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "power drinks"), and grape fruit (juice) from 48 hours prior to entry in the clinical research centre until discharge
• Medical history without major pathology
• All values for haematology and for clinical chemistry tests of blood and urine within normal range or showing no clinically relevant deviations as judged by the Medical Investigator
• Willingness to use adequate contraception from the time of dosing until three months after the end-of-study visit
• Willingness to sign the written Informed Consent Form (ICF)

You may not qualify if:

• Evidence of clinically relevant pathology
• Mental handicap
• History of relevant drug and/or food allergies
• At screening visit, abnormal 12-lead ECG of clinical relevance
• Regular/routine treatment with non-topical medication within 30 days prior to drug administration
• Irregular defecation pattern (less than once per two days)
• Exposure to radiation for diagnostic reasons (except dental X-days and plain X-rays of thorax and body skeleton (excluding spinal column)) during work or during participation in a medical trial in the previous year

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

PRA International

AE Zuitlaren, 9470, Netherlands

Location

MeSH Terms

Interventions

ORM-12741

Study Officials

• Jan Jaap van Lier

  PRA International, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 23, 2008
• First Posted: January 6, 2009
• Study Start: January 1, 2009
• Primary Completion: February 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 16, 2009

Record last verified: 2009-03

Locations

NL (1)