A drug-drug interaction study of DNL343 on midazolam in healthy participants

Phase 1

Completed

Conditions: Healthy volunteers
Not Applicable

Registration Number: ISRCTN26840121

Lead Sponsor: Denali Therapeutics Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 16

Inclusion Criteria

1. Healthy female participants of non-childbearing potential or healthy male participants between 18 and 65 years of age, inclusive
2. Body mass index (BMI) between 18.5 and 30 kg/m² and a body weight of at least 50 kg

Exclusion Criteria

1. Any history of hepatic, pulmonary, and/or renal disease
2. History of serious adverse reaction or serious hypersensitivity to any drug
3. History of allergy to any component of the study intervention
4. Have any surgical or medical condition affecting drug absorption (eg, gastrectomy)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MDZ PK parameters, as measured by laboratory analysis of plasma concentrations from blood samples including, but not limited to, the following at multiple timepoints over 25 days:<br>1. Maximum concentration (Cmax)<br>2. Time to reach maximum concentration (tmax)<br>3. Area under the concentration-time curve from time zero to infinity (AUC8)<br>4. Terminal elimination half-life (t1/2)

Secondary Outcome Measures

Name	Time	Method
1. Incidence of treatment-emergent adverse events (TEAEs) and SAEs as reported by the participant continuously over 25 days:<br>2. MDZ metabolite PK parameters, as measured by laboratory analysis of plasma concentrations from blood samples including, but not limited to, the following at multiple timepoints over 25 days:<br>2.1 Maximum concentration (Cmax)<br>2.2 Time to reach maximum concentration (tmax)<br>2.3 Area under the concentration-time curve from time zero to infinity (AUC8)<br>2.4 Terminal elimination half-life (t1/2)<br>3. DNL343 PK parameters, as measured by laboratory analysis of plasma concentrations from blood samples including, but not limited to, the following at multiple timepoints over 25 days:<br>3.1 AUC during a dosage interval (tau) (AUCt)<br>3.2 Maximum concentration at steady state (Cmax,ss)