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

Orion Pharma

Status and phase

Completed

Phase 1

Conditions

Healthy Male Volunteers

Treatments

Drug: ORM-12741

Study type

Interventional

Funder types

Industry

Identifiers

NCT00817544

3098004

Details and patient eligibility

About

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

Full 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.

Enrollment

6 estimated patients

Sex

Male

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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