A Phase 1, Drug-Drug Interaction Study of TBAJ-876 in Healthy Adults (NCT05526911) | Clinical Trial Compass
CompletedPhase 1
A Phase 1, Drug-Drug Interaction Study of TBAJ-876 in Healthy Adults
United States28 participantsStarted 2022-06-30
Plain-language summary
A Phase 1, Drug-Drug Interaction Study to Evaluate the Safety, Tolerability, and the Induction Potential of TBAJ-876 on CYP3A4 and P-glycoprotein and the Inhibition Potential of TBAJ-876 on P-glycoprotein in Healthy Adult Subjects
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Is a healthy adult male or female, 18 to 55 years of age (inclusive) at the time of screening.
* Has a body mass index (BMI) ≥18.5 and ≤32.0 (kg/m2) and a body weight of no less than 50.0 kg at the time of screening and check-in.
* Is medically healthy with no clinically significant screening results (e.g., laboratory profiles normal or up to Grade 1 per Division of Microbiology and Infectious Diseases (DMID) Toxicity Tables), as deemed by the Investigator.
* Has not used tobacco- or nicotine-containing products (including smoking cessation products), for a minimum of 6 months before dosing.
* Is willing and able to consume the entire high-calorie, high-fat breakfast meal in the timeframe required.
Key Exclusion Criteria:
* History or presence of significant cardiovascular abnormalities, heart murmur, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease as determined by the Investigator to be clinically relevant.
* Any musculoskeletal abnormality (severe tenderness with marked impairment of activity) or musculoskeletal toxicity (frank necrosis).
* Positive results at screening for Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HBsAg), or Hepatitis C antibodies (HCV).
* Positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) results within 6 days prior to Day 1.
* Current or history of prolonged QT syndrome.
* Family history of Long-QT…
What they're measuring
1
TBAJ-876 Effect on the Pharmacokinetics of the CYP-3A4 Substrate Midazolam in Healthy Adult Subjects: Pharmacokinetic Parameters AUC