AN OPEN-LABEL, SINGLE-DOSE, SINGLE-PERIOD STUDY DESIGNED TO ASSESS THE MASS BALANCE RECOVERY, METABOLITE PROFILE AND METABOLITE IDENTIFICATION OF [14C]-OLOROFIM ADMINISTERED VIA THE ORAL ROUTE TO HEALTHY MALE SUBJECTS.

AN OPEN-LABEL, SINGLE-DOSE, SINGLE-PERIOD STUDY DESIGNED TO ASSESS THE MASS BALANCE RECOVERY, METABOLITE PROFILE AND METABOLITE IDENTIFICATION OF [14C]-OLOROFIM ADMINISTERED VIA THE ORAL ROUTE TO HEALTHY MALE SUBJECTS. - [14C]-Olorofim

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48360

Enrollment

Registered

2019-06-27

Start date

2019-08-08

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Serious fungal infections

Interventions

Not applicable.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy males 18 - 55 years 50 - 100 kilograms BM) 18 - 30 kilograms/meter2 non smokers

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
• To assess the mass balance recovery after a single oral dose of [14C]-olorofim (Cohort A only) • To provide plasma, urine, bile and faecal samples for metabolite profiling and structural identification	—

Secondary

Measure	Time frame
• To determine the routes and rates of elimination of [14C]-olorofim • To identify the chemical structure of each metabolite accounting for more than 10% (by AUC) of circulating total radioactivity • To further explore the oral pharmacokinetics (PK) of [14C]-olorofim • To evaluate the extent of distribution of total radioactivity into blood cells (Cohort A only) • To evaluate the biliary elimination of olorofim-related material (Cohorts B1 and B2 only) • To provide additional safety and tolerability information for olorofim.	—

Measure

Time frame

• To determine the routes and rates of elimination of [14C]-olorofim • To identify the chemical structure of each metabolite accounting for more than 10% (by AUC) of circulating total radioactivity • To further explore the oral pharmacokinetics (PK) of [14C]-olorofim • To evaluate the extent of distribution of total radioactivity into blood cells (Cohort A only) • To evaluate the biliary elimination of olorofim-related material (Cohorts B1 and B2 only) • To provide additional safety and tolerability information for olorofim.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)