Radiolabeled zilurgisertib mass balance study

3 evidence topics · 2 sources

Objective

No evidence found.

Location and study date

No evidence found.

Study design

No evidence found.

Eligibility criteria

No evidence found.

Treatment

Single oral 400 mg dose of radiolabeled zilurgisertib

“Following a single oral 400 mg dose of radiolabeled zilurgisertib, 49% of the dose was recovered in feces (10% unchanged) and 38.5% in urine (28% unchanged).” (opens the prescribing information at this quote)

Study outcomes

Rationale for using recovery of administered radioactivity as the primary endpoint

No evidence found.

Statistical analysis description

Number of participants (Planned and analyzed)

No evidence found.

Description of analysis sets

No evidence found.

Results

Participant disposition

No evidence found.

Baseline characteristics

No evidence found.

Efficacy results

Recovery of the dose in feces and urine

“Following a single oral 400 mg dose of radiolabeled zilurgisertib, 49% of the dose was recovered in feces (10% unchanged) and 38.5% in urine (28% unchanged).” (opens the prescribing information at this quote)
“Zilurgisertib is predominantly metabolized by CYP3A4 and to a minor extent by CYP2D6.” (opens the prescribing information at this quote)

Health-related quality of life and patient-reported outcomes

Not applicable.

Safety results

No evidence found.

Study limitations

Summary: limitations of the mass balance evidence

The only public evidence of this study is one sentence of the prescribing information, which reports recovery of 49% of a single 400 mg radiolabeled dose in feces and 38.5% in urine, for a total of 87.5%. No publication or registry record was located, so the population, number of participants, dates, and safety results are unknown. The label's 28% of the dose excreted unchanged in urine is close to the 27% fraction excreted unchanged in urine after multiple doses in the multiple ascending dose study.