Status:
COMPLETED
Absorption, Metabolism and Excretion of 14C-olorofim in Man
Lead Sponsor:
F2G Biotech GmbH
Collaborating Sponsors:
PRA Health Sciences
Conditions:
Invasive Fungal Infections
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
Single-centre, open-label, non-randomised, single dose study in 2 cohorts of healthy subjects. It is planned to enrol 6 healthy male subjects in Cohort A (standard mass balance and metabolite profilin...
Detailed Description
Subjects will be screened up to 28 days prior to dosing and eligible subjects will be admitted to the Clinical Research Unit (CRU) on the day prior to dosing (Day-1). Each subject will be dosed on the...
Eligibility Criteria
Inclusion
- healthy males age 18 to 55 years of age with body mass index of 18 to 30 kg/m2 (inclusive), and a body weight of 50 to 100 kg (inclusive).
- Subjects must be in good health as determined by a medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia is NOT acceptable).
- Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day).
Exclusion
- Subjects with or history of clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatry, respiratory, metabolic, endocrine, ocular haematological or other major disorders as determined by the investigator
- Subjects who have received any prescribed systemic or topical medication within 14 days of the dose administration
- Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the dose administration
- Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the dose administration
- Current smokers and those who have smoked or used nicotine containing products (eg electronic cigarettes) within the 3 months prior to check-in.
- Radiation exposure, including that from the present study exceeding 1 mSv in the last 12 months or 5 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study.
Key Trial Info
Start Date :
July 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04039880
Start Date
July 30 2019
End Date
September 30 2019
Last Update
November 13 2019
Active Locations (1)
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1
PRA Health Sciences
Groningen, Netherlands, 9728