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

This study has been completed.
Information provided by:
Orion Corporation, Orion Pharma Identifier:
First received: December 23, 2008
Last updated: March 13, 2009
Last verified: March 2009
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

Condition Intervention Phase
Healthy Male Volunteers
Drug: ORM-12741
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Excretion Balance and Metabolism After a Single Oral Dose of 14C-Labelled ORM-12741; an Open, Non-Randomised, Single Centre Study in Healthy Male Subjects

Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:
  • The excretion balance of total 14C-radioactivity after a single oral dose of 14C-ORM-12741 [ Time Frame: 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 Outcome Measures:
  • To gain further information on the safety of ORM-12741 [ Time Frame: 2 months ]

Estimated Enrollment: 6
Study Start Date: January 2009
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ORM-12741
Drug: ORM-12741
3 mg of ORM-12741 as a single dose. Contains 0.73 mg (2.5 MBq) 14C labelled ORM-12741
Other Name: healthy volunteer

Detailed Description:

Six healthy males will receive 3 mg of ORM-12741 as a single oral solution(0.1mg/mL). The oral dose contains 0.73 mg of 14C-ORM-12741 (2.5 MBq), 1 mg of 13C-ORM-12741 and 1.27 mg of ORM-12741.

Subjects will be confined to the study site from Day -1 (the afternoon prior to the day of dosing) up to at least 168 hours following drug administration (Day 8). Subjects will be discharged on Day 8 if radioactivity in urine and faeces meet pre-defined criteria (urinary excretion <0.5% and faecal excretion <0.5% of the dose per 24 hours based on 14C radioactivity quick counts, which will be measured from Day 7 onwards). If on Day 8 these pre defined criteria are not met, subjects will remain hospitalised for a maximum of seven more days (Day 15) until the criteria are met (daily check on quick counts). If on Day 15 these pre defined criteria are not met, subjects will be discharged and requested to collect a 24-hour sample of urine and/or faeces at home once per week and to deliver this to the clinical research unit in Zuidlaren. These weekly collections will be continued until the criteria are met. The total duration of the study will be approximately 5 - 6 weeks for each subject.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00817544

PRA International
AE Zuitlaren, Netherlands, 9470
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Principal Investigator: Jan Jaap van Lier PRA International, The Netherlands
  More Information

Responsible Party: Orion Corporation, Orion Pharma (Leena Lehtonen, Clinical study director), Orion Corporation, Orion Pharma Identifier: NCT00817544     History of Changes
Other Study ID Numbers: 3098004
Study First Received: December 23, 2008
Last Updated: March 13, 2009

Keywords provided by Orion Corporation, Orion Pharma:
Healthy volunteers processed this record on April 28, 2017