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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Male Volunteers
• Intervention / Treatment: Drug: ORM-12741

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.

• Study Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • AE Zuitlaren, Netherlands, 9470
    • PRA International

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: healthy volunteer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
To gain further information on the safety of ORM-12741	2 months

Collaborators and Investigators

• Sponsor: Orion Corporation, Orion Pharma
• Investigators: Principal Investigator: Jan Jaap van Lier, PRA International, The Netherlands

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: December 23, 2008
• First Submitted That Met QC Criteria: January 5, 2009
• First Posted (Estimate): January 6, 2009

Study Record Updates

• Last Update Posted (Estimate): March 16, 2009
• Last Update Submitted That Met QC Criteria: March 13, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: Healthy volunteers; 3098004
• Other Study ID Numbers: 3098004