The purpose of this study is to characterize the effect of rifampicin and itraconazole on the PK of single dose of HDM1002 in healthy adult subjects. The safety and tolerability of HDM1002 and rifampicin or itraconazole when given separately or together will also be evaluated.
According to the medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination results during the screening period, the investigator considers the subject to be in good general health.
Age range of 18-45 years old (including range), no limit to gender.
Eligible male participant weighed ≥50.0 kg, eligible female participant weighed ≥45.0 kg, and had a body mass index (BMI) within the range of 19.0 - 32.0 kg/m2 (including cut-off values).
Participant has a history or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin≥50 ng/L during the screening period.
History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
History of acute cholecystitis within 3 month prior to initiation of screening period.
Participant judged by investigator has dysphagia, diseases or conditions that affect gastric emptying, or affect the absorption of gastrointestinal nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.
Parallel
HDM1002 and rifampicin
DrugAdministered orally
HDM1002 and itraconazole
DrugAdministered orally
AUC[0-∞] of HDM1002
Pharmacokinetics (PK) parameter : Area under the curve from time 0 hour to ∞
AUC[0-24 h] of HDM1002
PK parameter : Area under the curve from time 0 to 24 hour
Cmax of HDM1002
PK parameter : Maximum observed concentration
AUC[0-t] of HDM1002
PK parameters : Area under the curve from time 0 to t hour
AUC[0-∞] of HDM1002 metabolites
PK parameters : Area under the curve from time 0 hour to ∞
AUC[0-24 h] of HDM1002 metabolites
PK parameters : Area under the curve from time 0 to 24 hour
Cmax of HDM1002 metabolites
PK parameters : Maximum observed concentration
AUC[0-t] of HDM1002 metabolites
PK parameters : Area under the curve from time 0 to t hour
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