A Pharmacokinetic Interaction Study Between Apatinib Mesylate and Repaglinide or Bupropion in Advanced Solid Tumor Subjects

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT04457180
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 will be administered daily from on D5 through D16
  • Repaglinide — DRUG
    Repaglinide will be administered daily on D1 and D12
  • Bupropion — DRUG
    Bupropion will be administered daily on D2 and D13

Study Details

The primary objective of the study was to assess investigate the pharmacokinetic effects of Apatinib Mesylate on CYP2C8 Substrate Repaglinide or CYP2B6 Substrate Bupropion and metabolite Hydroxy bupropion in Advanced solid tumor subjects. The secondary objective of the study was to assess the safety of Apatinib or/and Repaglinide and Bupropion.

Key Dates

Start date
Nov 16, 2020
Status verified
Oct 2022
Primary completion
May 20, 2021
Completion
Jun 19, 2021

Study Design

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

Arms

  • Experimental: treatment
    In phase A, subjects receiving a single dose of Repaglinide orally on day 1 , a single dose of Bupropion orally on day 2 and wash-out for 10 days, then apatinib once daily will be conducted on D5 through D16 \# In addition, In phase B, subjects receiving a single dose of Repaglinide (in combination with apatinib) orally on day 12 , a single dose of Bupropion (in combination with apatinib) orally on day 13.

Primary Outcome Measure

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

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