Type2diabetesPhase 1Attractive 2NCT06432673
The Attractive 2 Trial - Pharmacokinetics of ATR-258 Oral Capsule vs. Oral Solution Formulations in Healthy Volunteers
A Phase 1 study testing ATR-258 Oral solution and ATR-258 Oral capsule in people with Type2diabetes, run by Atrogi AB at 1 site in Sweden.
Trial summary
This is a single-centre, open-label, randomised, 2-period cross-over, Phase 1 comparative trial to assess the ATR-258 pharmacokinetic (PK) parameters of an oral capsule formulation in comparison with an oral solution formulation, both given as single doses to healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type2diabetes
- What is being tested?
- ATR-258 Oral solution and ATR-258 Oral capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSweden
- Study dates
- 24 Apr 2024to 27 May 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of informed consent
- Body mass index ≥ 18.5 and ≤ 30.0
- Medically healthy participant
- Willing to use of double barrier contraceptive method if of childbearing potential
Who cannot join
- History or clinical manifestation of any clinically significant disease
- History of dysphagia or any other swallowing disorder
- Current smokers or users of nicotine products
- History or manifestation of drug abuse, alcohol abuse and/or excessive intake of alcohol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Attractive 2 Trial - An Open-label, Randomised, 2-period Cross-over Trial to Assess the Pharmacokinetics of ATR-258 Oral Capsule vs. Oral Solution Formulations in Healthy Volunteers
This is a single-centre, open-label, randomised, 2-period cross-over, Phase 1 comparative trial to assess the ATR-258 pharmacokinetic (PK) parameters of an oral capsule formulation in comparison with an oral solution formulation, both given as single doses to healthy volunteers. The order of treatment, i.e., the treatment sequence capsule - solution or solution - capsule, will be randomised.
- Conditions
- Type2diabetes
- Being tested
- ATR-258 Oral solution, ATR-258 Oral capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATR-258 Oral solutionDrug
Oral solution
ATR-258 Oral capsuleDrug
Oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Participants receive a single dose of ATR-28 in the order Oral capsule - Oral solution with a washout period in between. Receives: Drug: ATR-258 Oral solution; Drug: ATR-258 Oral capsule |
| Arm 2 | Experimental | Participants receive a single dose of ATR-28 in the order Oral solution - Oral capsule with a washout period in between. Receives: Drug: ATR-258 Oral solution; Drug: ATR-258 Oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC)
Measured: 48 hours
Peak Plasma Concentration (Cmax)
Measured: 48 hours
Secondary outcomes (5)
Time to maximum plasma concentration (Tmax)
Tmax
Measured: 48 hours
Half life in plasma (T1/2)
Measured: 48 hours
Apparent total body clearance following extravascular administration (CL/F)
Measured: 48 hours
Volume of distribution following extravascular administration (Vz/F)
Measured: 48 hours
Adverse events
Frequency, intensity and seriousness of reported adverse events
Measured: 7 days post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start24 Apr 2024
- Primary completion27 May 2024
- Study completion27 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2diabetesStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atrogi AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erik Waara, Study chair, Atrogi AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432673
- Sponsor's protocol ID
- ATR-258-trial-2
- Other IDs
- 2023-508797-28-00, 2023
- Acronym
- Attractive 2
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Attractive 2 Trial - An Open-label, Randomised, 2-period Cross-over Trial to Assess the Pharmacokinetics of ATR-258 Oral Capsule vs. Oral Solution Formulations in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06432673
- Acronym / sponsor ID
- Attractive 2 / ATR-258-trial-2
- Conditions
- Type2diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Atrogi ABIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 27 May 2024 (actual)
- Study completion
- 27 May 2024 (actual)
- First posted
- 29 May 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 single-centre, open-label, randomised, 2-period cross-over, Phase 1 comparative trial to assess the ATR-258 pharmacokinetic (PK) parameters of an oral capsule formulation in comparison with an oral solution formulation, both given as single doses to healthy volunteers. The order of treatment, i.e., the treatment sequence capsule - solution or solution - capsule, will be randomised.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: ATR-258 Oral solution, Drug: ATR-258 Oral capsuleParticipants receive a single dose of ATR-28 in the order Oral capsule - Oral solution with a washout period in between. |
| Arm 2 | Experimental | Drug: ATR-258 Oral solution, Drug: ATR-258 Oral capsuleParticipants receive a single dose of ATR-28 in the order Oral solution - Oral capsule with a washout period in between. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of informed consent
- Body mass index ≥ 18.5 and ≤ 30.0
- Medically healthy participant
- Willing to use of double barrier contraceptive method if of childbearing potential
Key exclusion criteria (4 listed)
- History or clinical manifestation of any clinically significant disease
- History of dysphagia or any other swallowing disorder
- Current smokers or users of nicotine products
- History or manifestation of drug abuse, alcohol abuse and/or excessive intake of alcohol
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 |
|---|---|---|
| ATR-258 Oral solutionOral solution | Drug | Arm 1, Arm 2 |
| ATR-258 Oral capsuleOral capsule | Drug | Arm 1, Arm 2 |
Primary outcome
Area under the plasma concentration versus time curve (AUC)
Time frame: 48 hours
Peak Plasma Concentration (Cmax)
Time frame: 48 hours
5 secondary outcomes
Time to maximum plasma concentration (Tmax)
Time frame: 48 hours
Half life in plasma (T1/2)
Time frame: 48 hours
Apparent total body clearance following extravascular administration (CL/F)
Time frame: 48 hours
Volume of distribution following extravascular administration (Vz/F)
Time frame: 48 hours
Adverse events
Time frame: 7 days post last dose
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 1 Jul 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.
Erik Waara study chair
Atrogi AB
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 ATR-258 Oral solution and ATR-258 Oral capsule in people with Type2diabetes, run by Atrogi AB at 1 site in Sweden.
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 4 inclusion and 4 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 1 Jul 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 Sweden. 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?
Area under the plasma concentration versus time curve (AUC) (time frame: 48 hours). The study lists 2 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 1 Jul 2024.