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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04581772