A Study to Evaluate the Effects of KarXT on the Drug Levels of Midazolam, Fexofenadine, and Digoxin

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorKaruna Therapeutics, Inc., a Bristol Myers Squibb company

About this trial

The purpose of this study is to evaluate the effects of KarXT administration on the drug levels of midazolam, fexofenadine, and digoxin in healthy adult participants.

Eligibility criteria

Qualifiers

Participants must be healthy male and female (INOCBP) as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECG, VS, and clinical laboratory determinations.

Participants must have BMI of 18.0 to 32.0 kg/m2.

Disqualifiers

Participants must not have organ dysfunction or any clinically significant deviation from normal in physical examination, VS, ECG, or clinical laboratory determinations beyond what is consistent with the target population reference ranges.

Participants must not have cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on the LFT results.

Participants must not have any other significant acute or chronic medical illness, as assessed by the investigator.

Participants must not have history or high risk of urinary retention, gastric retention, or narrow-angle glaucoma or known history of prostate hypertrophy or nocturia.

Trial design

Treatments tested in this trial

  • KarXT
  • Midazolam
  • Fexofenadine
  • Digoxin

Treatment groups

60 Participants
are divided into 4 treatment groups