A single-center, open-label, fixed-sequence, self-controlled phase I clinical trial aimed at evaluating the effect of itraconazole capsules(CYP3A inhibitor) on the pharmacokinetics of HS-10506 tablets in healthy participants.
On Day 1 and Day 11 of the trial, HS-10506 tablets will be orally administered under fasting conditions in the morning. From Day 7 to Day 15, itraconazole capsules (0.2 g, administered as two 0.1 g capsules) will be taken orally once daily for nine consecutive days. On the morning of Day 11, itraconazole capsules and HS-10506 tablets will be taken concurrently. When administered alone or in combination with itraconazole capsules, HS-10506 tablets will be given under fasting conditions. When administered alone, itraconazole capsules will be taken within 15 minutes after a meal, with approximately 240 mL of water.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
HS-10506: Administered under fasting conditions in the morning. Itraconazole: Itraconazole capsules (0.2 g) are taken orally once daily for nine consecutive days.
Qilu Hospital of Shandong University
Jinan, Shandong, China
Evaluation of PK parameters of HS-10506: Cmax
To evaluate the Cmax of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Time frame: 120 hours after administration of HS-10506
Evaluation of PK parameters of HS-10506: AUC0-t
To evaluate the AUC0-t of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Time frame: 120 hours after administration of HS-10506
Evaluation of PK parameters of HS-10506: AUC0-∞
To evaluate the AUC0-∞ of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Time frame: 120 hours after administration of HS-10506
Evaluation of PK parameters of HS-10506:Tmax
To evaluate the Tmax of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Time frame: 120 hours after administration of HS-10506
Evaluation of PK parameters of HS-10506: t1/2z
To evaluate the t1/2z of HS-10506 administered alone and in combination with Itraconazole in healthy participants
Time frame: 120 hours after administration of HS-10506
Evaluation of PK parameters of HS-10506: λz
To evaluate the λz of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Time frame: 120 hours after administration of HS-10506
Evaluation of PK parameters of HS-10506: CL/F
To evaluate the CL/F of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
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Time frame: 120 hours after administration of HS-10506
Evaluation of PK parameters of HS-10506: Vz/F
To evaluate the Vz/F of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Time frame: 120 hours after administration of HS-10506
Evaluation of PK parameters of HS-10506: MRT0-t
To evaluate the MRT0-t of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Time frame: 120 hours after administration of HS-10506
Evaluation of PK parameters of HS-10506: MRT0-∞
To evaluate the MRT0-∞ of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Time frame: 120 hours after administration of HS-10506
Adverse events
To evaluate the adverse events (AEs) of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Time frame: through study completion, an average of 36 days
blood pressure
To evaluate the blood pressure of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Time frame: through study completion, an average of 36 days
Pulse
To evaluate the Pulse of HS-10506 administered alone and in combination with Itraconazole in healthy participants
Time frame: through study completion, an average of 36 days
body temperature
To evaluate the body temperature of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Time frame: through study completion, an average of 36 days
oxygen saturation
To evaluate the oxygen saturation of HS-10506 administered alone and in combination with Itraconazole in healthy participants
Time frame: through study completion, an average of 36 days
complete blood count (CBC)
To evaluate the abnormal of complete blood count (CBC)of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Time frame: through study completion, an average of 36 days
urinalysis
To evaluate the abnormal of urinalysis of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Time frame: through study completion, an average of 36 days
blood chemistry
To evaluate the abnormal of blood chemistry of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Time frame: through study completion, an average of 36 days
coagulation tests
To evaluate the abnormal of coagulation tests of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Time frame: through study completion, an average of 36 days
thyroid function test (TFT)
To evaluate the abnormal of thyroid function test (TFT) of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Time frame: through study completion, an average of 36 days
Physical examination (include skin, mucous membranes and lymph nodes; head and neck; chest; abdomen; spine and extremities; nervous system, etc)
To evaluate the abnormal of physical examination of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Time frame: through study completion, an average of 36 days
12-lead electrocardiogram (include heart rate, PR, RR, QRS duration, QT interval and QTcF)
To evaluate the abnormal of 12-lead electrocardiogram of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Time frame: through study completion, an average of 36 days