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

This study has been completed.
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT00817544
First received: December 23, 2008
Last updated: March 13, 2009
Last verified: March 2009
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To gain further information on the safety of ORM-12741 [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

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
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 Names:
  • ORM-12741
  • 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817544

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

No publications provided

Responsible Party: Orion Corporation, Orion Pharma (Leena Lehtonen, Clinical study director), Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT00817544     History of Changes
Other Study ID Numbers: 3098004
Study First Received: December 23, 2008
Last Updated: March 13, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Orion Corporation, Orion Pharma:
3098004
Healthy volunteers

ClinicalTrials.gov processed this record on September 16, 2014