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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04581772




Registration number
NCT04581772
Ethics application status
Date submitted
29/09/2020
Date registered
9/10/2020
Date last updated
11/06/2021

Titles & IDs
Public title
A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy Volunteers
Scientific title
A Phase 1 Open-Label, Randomized, Crossover Study to Evaluate the Bioavailability, Effect of Food, Palatability, and Safety of Various DNL343 Oral Formulations in Healthy Participants
Secondary ID [1] 0 0
DNLI-F-0002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DNL343
Treatment: Drugs - Placebo
Treatment: Drugs - DNL343

Experimental: Cohort A -

Experimental: Cohort B -

Experimental: Cohort C -


Treatment: Drugs: DNL343
Multiple oral doses

Treatment: Drugs: Placebo
Single oral dose

Treatment: Drugs: DNL343
Single oral dose
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PK parameter: Maximum observed concentration (Cmax) of DNL343 in plasma
Timepoint [1] 0 0
Up to 15 days
Primary outcome [2] 0 0
PK parameter: Time to maximum observed concentration (Tmax) of DNL343 in plasma
Timepoint [2] 0 0
Up to 15 days
Primary outcome [3] 0 0
PK Parameter: Area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of DNL343 in plasma
Timepoint [3] 0 0
Up to 15 days
Primary outcome [4] 0 0
PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-8) of DNL343 in plasma
Timepoint [4] 0 0
Up to 15 days
Secondary outcome [1] 0 0
PK parameter: Maximum observed concentration (Cmax) of DNL343 in plasma in the fed versus fasted states
Timepoint [1] 0 0
Up to 15 days
Secondary outcome [2] 0 0
PK parameter: Time to maximum observed concentration (Tmax) of DNL343 in plasma in the fed versus fasted states
Timepoint [2] 0 0
Up to 15 days
Secondary outcome [3] 0 0
PK Parameter: Area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of DNL343 in plasma in the fed versus fasted states
Timepoint [3] 0 0
Up to 15 days
Secondary outcome [4] 0 0
PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-8) of DNL343 in plasma in the fed versus fasted states
Timepoint [4] 0 0
Up to 15 days
Secondary outcome [5] 0 0
Incidence of treatment-emergent adverse events (TEAEs)
Timepoint [5] 0 0
Up to 15 days

Eligibility
Key inclusion criteria
Key

* Body mass index (BMI) =18.5 to < 30 kg/m2 and body weight of at least 50 kg
* For women: Must have been surgically sterilized or be postmenopausal.

Key
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* History of clinically significant endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders
* History of malignancy, except fully resected basal cell carcinoma
* History of clinically significant neurologic or psychiatric diseases; head trauma with loss of consciousness; or clinically significant depression or suicidal ideation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/06/2021
Sample size
Target
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Denali Therapeutics Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 1 relative bioavailability study carried out in approximately 24 healthy male subjects and healthy female subjects of non childbearing potential to investigate the effects of formulation and food on the safety, tolerability, and pharmacokinetics (PK) of DNL343.
Trial website
https://clinicaltrials.gov/study/NCT04581772
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Richard Tsai, MD
Address 0 0
Denali Therapeutics Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04581772