A Open-label, Drug-Drug Interaction With SB_MDZ in Healty Adult Subjects

Phase 1

Active, not recruiting

• Conditions: Drug Drug Interaction (DDI)
• Interventions: Drug: SB17170; Drug: SB_MDZ

• Registration Number: NCT06846684
• Lead Sponsor: SPARK Biopharma

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-02-24
• Study First Posted: 2025-02-26
• Study Start: 2025-03-27
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2025-06-27
• Study Completion: 2025-06-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 12

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SB17170 + SB_MDZ	SB17170	-
SB17170 + SB_MDZ	SB_MDZ	-

Primary Outcome Measures

Name	Time	Method
AUC of SB_MDZ	Day 0, 6, 15
Cmax of SB_MDZ	Day 0, 6, 15

Secondary Outcome Measures

Name	Time	Method
Tmax of SB_MDZ	Day 0, 6, 15
AUCinf of SB_MDZ	Day 0, 6, 15
T1/s of SB_MDZ	Day 0, 6, 15
CL of SB_MDZ	Day 0, 6, 15
Vz of SB_MDZ	Day 0, 6, 15

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of