Clinical trial NCT06846684: A Open-label, Drug-Drug Interaction With SB_MDZ in Healty Adult Subjects
Official title: A Phase 1, Open-label, Fixed-sequence, Drug-drug Interaction Study to Investigate the Effect of Single and Multiple Oral Doses of SB17170 on the Pharmacokinetics of SB_MDZ in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Drug Drug Interaction (DDI)
Lead sponsor: SPARK Biopharma
Sponsor class: INDUSTRY
First posted: 2025-02-26
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This clinical trial is a phase 1, open-label, fixed-sequence, drug-drug interaction study to investigate the effect of single and multiple oral doses of SB17170 on the pharmacokinetics of SB_MDZ in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

1. Healthy adult subjects aged 19 to 50 years at the time of written consent.
2. Individuals with a body weight of ≥ 50.0 kg, and a Body Mass Index(BMI) of ≥ 18.0 kg/m2 and \< 30.0 kg/m2 at the time of screening ☞ BMI(kg/m2) = weight(kg) / {height(m)}2
3. Individuals who have voluntarily provided written consent to participate in the trial, after being fully informed about the study and agreeing to follow all precautions associated with participation.

Exclusion Criteria:

1. Individuals with a clinically significant disease or history in hepatobiliary, renal, nervous, respiratory, immune, hemato-oncology, cardiovascular, urinary system, or psychiatric disorder
2. Individuals with a history of a gastrointestinal disorders (gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal reflux disease, Crohn's disease, etc) or surgeries (except for simple appendectomy or hernia surgery) that may affect the safety and pharmacokinetic assessment of the investigational product (IP)
3. Individuals with hypersensitivity or significant history of hypersensitivity to drugs, including ingredients of the IP (SB17170 or its metabolite SB1703, SB_MDZ, and benzodiazepine-class drugs) or other drugs (e.g., aspirin, antibiotics)
4. Individuals with a current or historical condition that may increase risk, as determined by the investigator or as indicated in SB_MDZ's product information
5. Individuals who exhibited one or more of the following results in clinical laboratory tests during the screening, including additional tests

   * AST (SGOT), ALT (SGPT) \> 60 IU/L
   * Estimated glomerular filtration rate (eGFR, CKD-EPI equation): \< 60 mL/min/1.73m2
   * Individuals with a positive result on serology tests (heapatitis B, hepatitis C, human immunodeficiency virus (HIV) and syphilis tests)

Primary outcomes:
measure: Cmax of SB_MDZ
timeFrame: Day 0, 6, 15
measure: AUC of SB_MDZ
timeFrame: Day 0, 6, 15
Secondary outcomes:
measure: Tmax of SB_MDZ
timeFrame: Day 0, 6, 15
measure: AUCinf of SB_MDZ
timeFrame: Day 0, 6, 15
measure: T1/s of SB_MDZ
timeFrame: Day 0, 6, 15
measure: CL of SB_MDZ
timeFrame: Day 0, 6, 15
measure: Vz of SB_MDZ
timeFrame: Day 0, 6, 15
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: