Healthy volunteers Not Applicable
Conditions
Interventions
Treatment Period 1: Single oral dose of MDZ
Treatment Period 2: Once daily oral dose of DNL343 for 14 days then coadministered with a single dose of MDZ on the 14th day
Sponsors
Denali Therapeutics Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: 1. Maximum concentration (Cmax) 2. Time to reach maximum concentration (tmax) 3. Area under the concentration-time curve from time zero to infinity (AUC8) 4. Terminal elimination half-life (t1/2) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of treatment-emergent adverse events (TEAEs) and SAEs as reported by the participant continuously over 25 days: 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: 2.1 Maximum concentration (Cmax) 2.2 Time to reach maximum concentration (tmax) 2.3 Area under the concentration-time curve from time zero to infinity (AUC8) 2.4 Terminal elimination half-life (t1/2) 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: 3.1 AUC during a dosage interval (tau) (AUCt) 3.2 Maximum concentration at steady state (Cmax,ss) | — |
Countries
United Kingdom, Wales
Contacts
Public ContactGabrielle;Clinical Trials Disclosures Group Brill;-
;
Outcome results
None listed