CompletedPhase 1

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

South Korea12 participantsStarted 2025-03-27

Plain-language 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.

Who can participate

Age range19 Years – 50 Years

SexALL

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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

What they're measuring

Cmax of SB_MDZ

Timeframe: Day 0, 6, 15

AUC of SB_MDZ

Timeframe: Day 0, 6, 15

Trial details

NCT IDNCT06846684

SponsorSPARK Biopharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-10

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