A Pharmacokinetic Interaction Study Between Apatinib Mesylate and Transporter Pgp Substrate Digoxin in Advanced Solid Tumor Subjects

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT04322552
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib Mesylate — DRUG
    Apatinib at a dosage of will be administered daily from on D5 through D16
  • Digoxin tablet — DRUG
    Digoxin at a dosage of 0.25mg will be administered at day 1 and day 12

Study Details

Apatinib, an oral inhibitor of vascular endothelial growth factor receptor 2#VEGFR-2#, Induces Transporter Pgp function in vitro. This study in patients with advanced cancer evaluated the effect of Apatinib on Transporter Pgp function by comparing the pharmacokinetics of Transporter Pgp-specific probe drugs in the presence and absence of Apatinib. The probes used Substrate Digoxin.

Key Dates

Start date
Mar 12, 2020
Status verified
Mar 2020
Primary completion
Apr 3, 2021
Completion
May 3, 2021

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treament
    In phase A, subjects receiving a single 0.25 mg of digoxin orally and wash-out for 5 days, then apatinib once daily will be conducted on D5 through D16 ； In addition, a single dose of 0.25 mg digoxin (in combination with apatinib) will be orally administered in fasting conditions on D12；

Primary Outcome Measure

Pharmacokinetics parameter: Cmax of digoxin [ Time Frame: through study completion, an average of 16 days ]

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