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

SPARK Biopharma

Status and phase: Completed; Phase 1

Conditions: Drug Drug Interaction (DDI)

Treatments: Drug: SB_MDZ; Drug: SB17170

Study type: Interventional

Funder types: Industry

Identifiers

NCT06846684

SMARTT-003

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

SB17170 + SB_MDZ

Experimental group

Treatment:

Drug: SB17170

Drug: SB_MDZ