Study to Evaluate the Effect of Rabeprazole Sodium Enteric-coated Tablets on the Pharmacokinetics of TQ05105 Tablets

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT07608666
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • TQ05105 tablets — DRUG
    TQ05105 tablets are Janus kinase (JAK) inhibitors.
  • Rabeprazole sodium enteric-coated tablets — DRUG
    Rabeprazole sodium enteric-coated tablets.

Study Details

Primary objective: To evaluate the effect of rabeprazole on the primary pharmacokinetics of TQ05105 tablets. Secondary objective: To assess the safety and tolerability of single oral administration of TQ05105 tablets alone and in combination with rabeprazole in healthy study participants. To evaluate the effect of rabeprazole on the secondary PK parameters of TQ05105 and the pharmacokinetics of its active metabolite TQ12550.

Key Dates

First listed
May 27, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
17 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Other: TQ05105 tablets
    TQ05105 tablets combined with rabeprazole sodium enteric-coated tablets, 14 days as a treatment cycle.

Primary Outcome Measure

Peak concentration (Cmax) [ Time Frame: 1 hour before administration, and 10, 20 minutes, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 24 hours after administration ]

Central Contacts

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