A phase 1 study to evaluate the absorption, metabolism and excretion of BCX7353 following administration of a single, oral dose of [14C]-radiolabeled BCX7353 to healthy male subjects.

A phase 1 study to evaluate the absorption, metabolism and excretion of BCX7353 following administration of a single, oral dose of [14C]-radiolabeled BCX7353 to healthy male subjects. - BCX7353 ADME Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44289

Enrollment

Registered

2017-08-14

Start date

2017-09-07

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

Generische aandoening. extremities gastrointestinal tract and upper airways. genitals Swelling of face

Interventions

Not applicable.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male subjects 18 - 65 years BMI 18.0 - 32.0 kilograms/meter2 non smoking

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 determine the mass balance of [14C]-BCX7353.	—

Secondary

Measure	Time frame
To determine the radioprofile and identify metabolites of [14C]-BCX7353 in plasma, urine and feces following a single oral dose of [14C]-BCX7353 To assess the pharmacokinetics (PK) of BCX7353 in plasma and urine following administration of an oral dose of [14C]-BCX7353 To assess the PK of total radioactivity in plasma To assess the exposure of notable radiolabeled components using AUC pooling To provide additional safety and tolerability information for BCX7353	—

Measure

Time frame

To determine the radioprofile and identify metabolites of [14C]-BCX7353 in plasma, urine and feces following a single oral dose of [14C]-BCX7353 To assess the pharmacokinetics (PK) of BCX7353 in plasma and urine following administration of an oral dose of [14C]-BCX7353 To assess the PK of total radioactivity in plasma To assess the exposure of notable radiolabeled components using *AUC pooling* To provide additional safety and tolerability information for BCX7353

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)