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OpenTrials
Completed

NCT Number: NCT06846684

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

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.

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Key information

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adult subjects aged 19 to 50 years at the time of written consent.
  • 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
  • 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

  • Individuals with a clinically significant disease or history in hepatobiliary, renal, nervous, respiratory, immune, hemato-oncology, cardiovascular, urinary system, or psychiatric disorder
  • 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)
  • 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)
  • 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
  • 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)

Treatment and study plan

SB17170

Drug

PO, QD

SB_MDZ

Drug

IV

Primary outcomes

  1. Cmax of SB_MDZ

    Time frame: Day 0, 6, 15

  2. AUC of SB_MDZ

    Time frame: Day 0, 6, 15

Secondary outcomes

  1. Tmax of SB_MDZ

    Time frame: Day 0, 6, 15

  2. AUCinf of SB_MDZ

    Time frame: Day 0, 6, 15

  3. T1/s of SB_MDZ

    Time frame: Day 0, 6, 15

  4. CL of SB_MDZ

    Time frame: Day 0, 6, 15

  5. Vz of SB_MDZ

    Time frame: Day 0, 6, 15

Sponsors and collaborators

Lead sponsor

SPARK Biopharma

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 26, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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