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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06846684

Enrollment

Registered

2025-02-26

Start date

2025-03-27

Completion date

2025-09-12

Last updated

2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Drug Interaction (DDI)

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.

Interventions

DRUGSB17170

PO, QD

DRUGSB_MDZ

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 50 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Cmax of SB_MDZ	Day 0, 6, 15
AUC of SB_MDZ	Day 0, 6, 15

Secondary

Measure	Time frame
T1/s of SB_MDZ	Day 0, 6, 15
Tmax of SB_MDZ	Day 0, 6, 15
Vz of SB_MDZ	Day 0, 6, 15
CL of SB_MDZ	Day 0, 6, 15
AUCinf of SB_MDZ	Day 0, 6, 15

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026