WO2024138005A1 example 7

7 evidence topics · 1 source

Objective

Formulation comparison objective

“pharmacokinetics and relative bioavailability” (opens the source at this quote in a new tab)

Location and study date

No evidence found.

Study design

Single-center crossover formulation comparison

“single-center, open-label, 2-period, randomized, crossover” (opens the source at this quote in a new tab)

Eligibility criteria

Study population

“healthy adult subjects” (opens the source at this quote in a new tab)

Treatment

Single-dose cohorts for formulations A and B

Cohort	Dose
1	“50 mg”
2	“300 mg”
3	“600 mg”

Study outcomes

Rationale for using pharmacokinetics and relative bioavailability as the study endpoints

Not applicable.

Statistical analysis description

Number of participants (Planned and analyzed)

Participants receiving the three initial dose levels

“Thirty subjects (10/cohort)” (opens the source at this quote in a new tab)

Description of analysis sets

No evidence found.

Results

Participant disposition

No evidence found.

Baseline characteristics

No evidence found.

Efficacy results

Pharmacokinetic results: absorption

“Bezuclastinib was slowly absorbed after oral administration, reaching median time to maximum concentration 12 to 16 hours post dose.” (opens the source at this quote in a new tab)

Health-related quality of life and patient-reported outcomes

Not applicable.

Safety results

Study limitations

Summary

The formulation comparison included 30 healthy-adult participants in a single-center, open-label crossover study. These single-dose pharmacokinetic observations do not establish efficacy or long-term safety in nonadvanced SM. The source does not disclose a trial acronym or protocol number; the study is identified here by the patent's Example 7.