A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy Volunteers

NCT04581772 | Completed Phase 1

• 1 other identifier: DNLI-F-0002
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• PK parameter: Maximum observed concentration (Cmax) of DNL343 in plasma

  Up to 15 days

• PK parameter: Time to maximum observed concentration (Tmax) of DNL343 in plasma

  Up to 15 days

• PK Parameter: Area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of DNL343 in plasma

  Up to 15 days

• PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL343 in plasma

  Up to 15 days

Secondary Outcomes (5)

• PK parameter: Maximum observed concentration (Cmax) of DNL343 in plasma in the fed versus fasted states

  Up to 15 days

• PK parameter: Time to maximum observed concentration (Tmax) of DNL343 in plasma in the fed versus fasted states

  Up to 15 days

• 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

  Up to 15 days

• PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL343 in plasma in the fed versus fasted states

  Up to 15 days

• Incidence of treatment-emergent adverse events (TEAEs)

  Up to 15 days

Study Arms (3)

Cohort A

EXPERIMENTAL

Drug: DNL343; Drug: Placebo

Cohort B

EXPERIMENTAL

Drug: DNL343; Drug: Placebo

Cohort C

EXPERIMENTAL

Drug: DNL343

Interventions

DNL343 DRUG

Multiple oral doses

Cohort A; Cohort B

Placebo DRUG

Single oral dose

Cohort A; Cohort B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Denali Therapeutics Inc.: lead

Study Sites (1)

Auckland Clinical Studies Ltd.

Grafton, Auckland, New Zealand

Location

Study Officials

• Richard Tsai, MD

  Denali Therapeutics Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 9, 2020
• Study Start: December 23, 2020
• Primary Completion: June 4, 2021
• Study Completion: June 4, 2021
• Last Updated: June 11, 2021

Record last verified: 2021-06

Locations

NZ (1)