PharmacokineticsPhase 1NCT05330858
Relative Bioavailability of ESK-001 Tablet Versus Liquid in Healthy Participants
A Phase 1 study testing ESK-001 and Rabeprazole in people with Pharmacokinetics, run by Alumis Inc at 1 site in United States.
Trial summary
This is a single-center, in-house, open-label, crossover study in 15 healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- ESK-001 and Rabeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2022to 20 Sep 2022
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Men and woman age 18-60
- Able to provide written informed consent
- Females can not be pregnant or lactating
Who cannot join
- Prior exposure to ESK-001
- History of malignancy within the last 10 years
- Positive for HIV, Hepatitis B or C
- History of tuberculosis
- Positive test for alcohol or drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relative Bioavailability of an ESK-001 Tablet Versus Liquid Formulation, and the Effect of Food or Gastric Acid Reduction on the Pharmacokinetics of ESK-001 in Healthy Participants
This is a single-center, in-house, open-label, crossover study in 15 healthy participants.
Read the detailed description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
- Conditions
- Pharmacokinetics
- Being tested
- ESK-001, Rabeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESK-001Drug
Oral tablet or liquid
RabeprazoleDrug
Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| ESK-001 Liquid | Experimental | ESK-001 administered as an oral liquid Receives: Drug: ESK-001 |
| ESK-001 Tablet Fasted | Experimental | ESK-001 administered as an oral tablet in the fasted state Receives: Drug: ESK-001 |
| ESK-001 Tablet Fed | Experimental | ESK-001 administered as an oral tablet in the fed state Receives: Drug: ESK-001 |
| ESK-001 and Rabeprazole | Experimental | ESK-001 administered as an oral tablet with rabeprazole Receives: Drug: ESK-001; Drug: Rabeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the PK parameters of ESK-001 via time of maximum plasma concentration (Tmax)
Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples between dosing arms
Measured: 18 Days
Assess the PK parameters of ESK-001 via maximum plasma concentration (Cmax)
Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples between dosing arms
Measured: 18 Days
Assess the PK parameters of ESK-001 via area under the concentration time curve (AUC)
Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples between dosing arms
Measured: 18 Days
Secondary outcomes (1)
Assess the Incidence of Treatment Emergent Adverse Events of ESK-001
Collection and review of incidence of adverse events and serious adverse events
Measured: 25 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start17 Mar 2022
- Primary completion30 Jun 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alumis Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330858
- Sponsor's protocol ID
- ESK-001-002
- Status last verified
- May 2023
- First submitted
- 30 Mar 2022
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- 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 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relative Bioavailability of an ESK-001 Tablet Versus Liquid Formulation, and the Effect of Food or Gastric Acid Reduction on the Pharmacokinetics of ESK-001 in Healthy Participants
- ClinicalTrials.gov ID
- NCT05330858
- Acronym / sponsor ID
- ESK-001-002
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Alumis IncIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 15 Apr 2022 (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 single-center, in-house, open-label, crossover study in 15 healthy participants.
Detailed description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ESK-001 Liquid | Experimental | Drug: ESK-001ESK-001 administered as an oral liquid |
| ESK-001 Tablet Fasted | Experimental | Drug: ESK-001ESK-001 administered as an oral tablet in the fasted state |
| ESK-001 Tablet Fed | Experimental | Drug: ESK-001ESK-001 administered as an oral tablet in the fed state |
| ESK-001 and Rabeprazole | Experimental | Drug: ESK-001, Drug: RabeprazoleESK-001 administered as an oral tablet with rabeprazole |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Men and woman age 18-60
- Able to provide written informed consent
- Females can not be pregnant or lactating
Key exclusion criteria (5 listed)
- Prior exposure to ESK-001
- History of malignancy within the last 10 years
- Positive for HIV, Hepatitis B or C
- History of tuberculosis
- Positive test for alcohol or drugs
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 |
|---|---|---|
| ESK-001Oral tablet or liquid | Drug | ESK-001 Liquid, ESK-001 Tablet Fasted, ESK-001 Tablet Fed, ESK-001 and Rabeprazole |
| RabeprazoleOral Tablet | Drug | ESK-001 and Rabeprazole |
Primary outcome
Assess the PK parameters of ESK-001 via time of maximum plasma concentration (Tmax)
Time frame: 18 Days
Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples between dosing arms
Assess the PK parameters of ESK-001 via maximum plasma concentration (Cmax)
Time frame: 18 Days
Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples between dosing arms
Assess the PK parameters of ESK-001 via area under the concentration time curve (AUC)
Time frame: 18 Days
Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples between dosing arms
1 secondary outcome
Assess the Incidence of Treatment Emergent Adverse Events of ESK-001
Time frame: 25 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 9 May 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 ESK-001 and Rabeprazole in people with Pharmacokinetics, run by Alumis 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 3 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 9 May 2023. 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?
Assess the PK parameters of ESK-001 via time of maximum plasma concentration (Tmax) (time frame: 18 Days). The study lists 3 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 9 May 2023.