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

Healthy Male Volunteers Clinical Trial

— ALMAS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00817544
• Other study ID #: 3098004
• Status: Completed
• Phase: Phase 1
• First received: December 23, 2008
• Last updated: March 13, 2009
• Start date: January 2009
• Est. completion date: March 2009

Study information

• Verified date: March 2009
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Male Volunteers

Intervention

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

Locations

Country	Name	City	State
Netherlands	PRA International	AE Zuitlaren

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	To gain further information on the safety of ORM-12741		2 months	Yes