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Completed

NCT Number: NCT04581772

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Auckland Clinical Studies Ltd.

Grafton, Auckland, New Zealand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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 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

Treatment and study plan

DNL343

Drug

Multiple oral doses

Placebo

Drug

Single oral dose

Primary outcomes

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

    Time frame: Up to 15 days

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

    Time frame: Up to 15 days

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

    Time frame: Up to 15 days

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

    Time frame: Up to 15 days

Secondary outcomes

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

    Time frame: Up to 15 days

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

    Time frame: Up to 15 days

  3. 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

    Time frame: Up to 15 days

  4. 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

    Time frame: Up to 15 days

  5. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: Up to 15 days

Sponsors and collaborators

Lead sponsor

Denali Therapeutics Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 9, 2020
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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