Healthy volunteers Not Applicable
Conditions
Interventions
Treatment Period 1: Single oral dose of MDZ
Treatment Period 2: Once daily oral dose of BIIB122/DNL151 for 10 consecutive days, coadministered with a single dose of MDZ on the 10th day
The total dura
at Visit 2, participants will be confined in a clinical research unit for 13 days
at Visit 3, participants will have an outpatient visit at the clinical research unit.
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 50 years of age, inclusive 2. Body mass index (BMI) between 18.5 and 31.0 kg/m² and a body weight of at least 50 kg
Exclusion criteria
Exclusion criteria: 1. Take any concomitant medication at the time of screening or during the study, unless deemed acceptable by the investigator (or designee) and Sponsor 2. Any history of hepatic, pulmonary, and/or renal disease 3. History of serious adverse reaction or serious hypersensitivity to any drug 4. History of allergy to any component of the study intervention 5. Have any surgical or medical condition affecting drug absorption (eg, gastrectomy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BIIB122/DNL151 and MDZ PK parameters, as measured by laboratory analysis of plasma concentrations from blood samples, including, but not limited to, the following: 1. Maximum concentration (Cmax) 2. Area under the concentration-time curve from time zero to infinity (AUC8) 3. Area under the concentration-time curve from time zero to time of last measurable concentration (AUClast) 4. AUC during a dosage interval (tau) (AUCt) [Timeframe: Multiple timepoints over 15 days] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. BIIB122/DNL151 and MDZ PK parameters, as measured by laboratory analysis of plasma concentrations from blood samples, including, but not limited to, the following: 1.1. Time to maximum concentration (tmax) 1.2. Terminal elimination half-life (t1/2) [Timeframe: Multiple timepoints over 15 days] 2.Safety assessment including: 2.1. Incidence of treatment-emergent adverse events (TEAEs) and SAEs as reported by the participant [Timeframe: Continuously over 15 days] 2.2. Laboratory assessments of blood and urine samples (including hematology, serum clinical chemistry, and urinalysis) [Timeframe: Multiple timepoints over 15 days] 2.3. 12-lead electrocardiograms (ECGs) [Timeframe: Multiple timepoints over 15 days] 2.4. Vital sign abnormalities [Timeframe: Multiple timepoints over 15 days] 2.5. Physical examinations [Timeframe: Multiple timepoints over 15 days] 2.6. Suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) [Timeframe: Multiple timepoints over 15 days] | — |
Countries
United Kingdom, Wales
Contacts
Public ContactGabrielle;Clinical Trials Disclosures Group Brill;-
;
Outcome results
None listed