Healthy VolunteersPhase 1NCT06281158
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants
A Phase 1 study testing [14C]-DNL343 in people with Healthy Volunteers, run by Denali Therapeutics Inc. at 1 site in United States.
Trial summary
This is a Phase 1, open-label, nonrandomized, single-dose study in healthy male participants to investigate the absorption, metabolism and excretion of DNL343. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [14C]-DNL343
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 30 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males, aged between 18 to 65 years, inclusive
- Body mass index between 18.0 and 32.0 kg/m2
- In good health
- When engaging in sex with a woman of child bearing potential, both the male participant and his female partner must use highly effective contraception
- History of a minimum of 1 bowel movement per day
Who cannot join
- History or clinical manifestation of any clinically significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
- Have a history of malignancy, except fully resected basal cell carcinoma
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- Have previously completed or withdrawn from this study or any other study investigating DNL343 and have previously received DNL343
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of the Pharmacokinetics of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants
This is a Phase 1, open-label, nonrandomized, single-dose study in healthy male participants to investigate the absorption, metabolism and excretion of DNL343.
- Conditions
- Healthy Volunteers
- Being tested
- [14C]-DNL343
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-DNL343Drug
Single dose
| Study group | Role | What they receive |
|---|---|---|
| 14C-DNL343 | Experimental | Not described Receives: Drug: [14C]-DNL343 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK Parameter: AUC0-∞
The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL343 in plasma
Measured: 28 days
PK Parameter: AUC0-tlast
Area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-tlast) of DNL343 in plasma
Measured: 28 days
PK Parameter: Cmax
Maximum observed concentration (Cmax) of DNL343 in plasma
Measured: 28 days
PK Parameter: Tmax
Time to maximum observed concentration (Tmax) of DNL343 in plasma
Measured: 28 days
PK Parameter: t1/2
Terminal elimination half-life (t1/2) of DNL343 in plasma
Measured: 28 days
Total radioactivity in plasma and whole blood
Measured: 28 days
Total radioactivity in blood-to-plasma ratio
Measured: 28 days
Extent and rate of recovery of total radioactivity in urine and feces
Measured: 28 days
Secondary outcomes (7)
PK Parameter: AUC0-∞
The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of a DNL343 metabolite in plasma
Measured: 28 days
PK Parameter: AUC0-tlast
Area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-tlast) of a DNL343 metabolite in plasma
Measured: 28 days
PK Parameter: Cmax
Maximum observed concentration (Cmax) of a DNL343 metabolite in plasma
Measured: 28 days
PK Parameter: Tmax
Time to maximum observed concentration (Tmax) of a DNL343 metabolite in plasma
Measured: 28 days
PK Parameter: t1/2
Terminal elimination half-life (t1/2) of a DNL343 metabolite in plasma
Measured: 28 days
DNL343 and a DNL343 metabolite recoveries in urine
Measured: 28 days
Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Mar 2024
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denali Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ana-Claire Meyer, MD, Study director, Denali Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281158
- Sponsor's protocol ID
- DNLI-F-0009
- Status last verified
- Jun 2024
- First submitted
- 20 Feb 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Pharmacokinetics of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT06281158
- Acronym / sponsor ID
- DNLI-F-0009
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Denali Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, open-label, nonrandomized, single-dose study in healthy male participants to investigate the absorption, metabolism and excretion of DNL343.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 14C-DNL343 | Experimental | Drug: [14C]-DNL343 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males, aged between 18 to 65 years, inclusive
- Body mass index between 18.0 and 32.0 kg/m2
- In good health
- When engaging in sex with a woman of child bearing potential, both the male participant and his female partner must use highly effective contraception
- History of a minimum of 1 bowel movement per day
Key exclusion criteria (5 listed)
- History or clinical manifestation of any clinically significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
- Have a history of malignancy, except fully resected basal cell carcinoma
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- Have previously completed or withdrawn from this study or any other study investigating DNL343 and have previously received DNL343
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]-DNL343Single dose | Drug | 14C-DNL343 |
Primary outcome
PK Parameter: AUC0-∞
Time frame: 28 days
The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL343 in plasma
PK Parameter: AUC0-tlast
Time frame: 28 days
Area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-tlast) of DNL343 in plasma
PK Parameter: Cmax
Time frame: 28 days
Maximum observed concentration (Cmax) of DNL343 in plasma
PK Parameter: Tmax
Time frame: 28 days
Time to maximum observed concentration (Tmax) of DNL343 in plasma
PK Parameter: t1/2
Time frame: 28 days
Terminal elimination half-life (t1/2) of DNL343 in plasma
Total radioactivity in plasma and whole blood
Time frame: 28 days
Total radioactivity in blood-to-plasma ratio
Time frame: 28 days
Extent and rate of recovery of total radioactivity in urine and feces
Time frame: 28 days
7 secondary outcomes
PK Parameter: AUC0-∞
Time frame: 28 days
PK Parameter: AUC0-tlast
Time frame: 28 days
PK Parameter: Cmax
Time frame: 28 days
PK Parameter: Tmax
Time frame: 28 days
PK Parameter: t1/2
Time frame: 28 days
DNL343 and a DNL343 metabolite recoveries in urine
Time frame: 28 days
Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana-Claire Meyer, MD study director
Denali Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]-DNL343 in people with Healthy Volunteers, run by Denali Therapeutics Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK Parameter: AUC0-∞ (time frame: 28 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.