CompletedPhase 1

Fruquintinib CYP3A Inhibitor and Inducer Study

United States28 participantsStarted 2020-09-02

Plain-language summary

A study to assess the effect of itraconazole, a strong CYP3A inhibitor, and the effect of rifampin, a strong CYP3A inducer, on the pharmacokinetics of fruquintinib in healthy subjects.

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. Hormonal contraception (as the partner will not be taking the study investigational product \[IP\]) along with male subject's condom with spermicide
✓. Intrauterine device (hormonal or non-hormonal) along with male subject's condom with spermicide
✓. Bilateral tubal ligation
✓. Depo Provera along with male subject's condom with spermicide Abstinence is allowed (6 months of true abstinence), including same sex partners.

What they're measuring

AUC (0-t) of fruquintinib

Timeframe: up to 26 days

AUC (0-inf) of fruquintinib

Timeframe: up to 26 days

Cmax of fruquintinib

Timeframe: up to 26 days

Trial details

NCT IDNCT04557397

SponsorHutchison Medipharma Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-10-18

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