HealthyPhase 1NCT05549531
A Study to Investigate the Effect of Itraconazole on the Way the Body Absorbs, Distributes, and Gets Rid of ACT-1004-1239 Given as a Single Dose of 10 mg to Healthy Male Subjects
A Phase 1 study testing ACT-1004-1239 (10 mg) and Itraconazole (200 mg, o.d.) in people with Healthy, run by Idorsia Pharmaceuticals Ltd. at 1 site in Portugal.
Trial summary
A study to investigate the effect of itraconazole on the way the body absorbs, distributes, and gets rid of ACT-1004-1239 given as a single dose of 10 mg to healthy male subjects Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ACT-1004-1239 (10 mg) and Itraconazole (200 mg, o.d.)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Oct 2022to 20 Oct 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
- Healthy male subject aged between 18 and 55 years (inclusive) at Screening.
- Negative SARS-CoV-2 test or valid EU Digital COVID-19 Recovery Certificate prior to Day -1.
- A male subject with a partner of childbearing potential must use adequate contraception (i.e., condom) from first study treatment administration up to at least 30 days after EOS or premature study discontinuation (i.e., safety follow-up).
Who cannot join
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- Participation in a clinical study involving study treatment administration within 12 weeks prior to Screening or in more than 2 clinical studies within 1 year prior to Screening.
- History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to Screening.
- Previous treatment with any prescribed medications (including vaccines such as COVID-19 vaccine) or OTC medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 3 weeks prior to first study treatment administration.
- Positive results from urine drug and alcohol screen at Screening, on Day -1.
- Positive serology results for HIV1 and HIV2 antibodies, hepatitis B surface antigen, and hepatitis C antibodies at Screening.
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- Any signs or symptoms of an acute clinically relevant illness within 4 weeks prior to Screening (e.g., bacterial, viral, or fungal infection) as judged by the investigator.
- Any cardiac condition or illness that may jeopardize the safety of the study subject as per the investigator's judgment based on medical history or 12-lead ECG measured at Screening.
- Any immunosuppressive treatment within 6 weeks or 5 x t½, whichever is longer, before first study treatment administration.
- Clinically relevant abnormalities or abnormalities of uncertain clinical significance on 12-lead ECG, measured after 5 min in a supine position at Screening or on Day -1.
- Baseline QTc interval >450 ms or <350 ms at Screening or on Day -1.
- Alanine aminotransferase, aspartate aminotransferase, or creatinine kinase values above the upper limit of the normal range at Screening.
- Estimated renal creatinine clearance (CrCL) below 90 mL/min, based on creatinine clearance calculation by the Cockcroft-Gault formula and normalized to an average surface area of 1.73 m2 at Screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open-label, Fixed-sequence Study to Investigate the Effect of Multiple-dose Itraconazole on the Pharmacokinetics of a Single Dose of 10 mg ACT-1004-1239 in Healthy Male Subjects
A study to investigate the effect of itraconazole on the way the body absorbs, distributes, and gets rid of ACT-1004-1239 given as a single dose of 10 mg to healthy male subjects
- Conditions
- Healthy
- Being tested
- ACT-1004-1239 (10 mg), Itraconazole (200 mg, o.d.)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-1004-1239 (10 mg)Drug
ACT-1004-1239 will be administered as 1 capsule of 10 mg strength to be taken under fed conditions.
Itraconazole (200 mg, o.d.)Drug
Itraconazole 200 mg will be administered as capsules (2 x 100 mg capsule) to be taken under fed conditions.
| Study group | Role | What they receive |
|---|---|---|
| Investigational and interaction treatment | Experimental | ACT-1004-1239 (10 mg) will be administered on Day 1 (in Treatment A) and Day 9 (in Treatment B2).
Itraconazole (200 mg, o.d.) will be administered from Day 6 until Day 13. On Day 9, itraconazole will be administered concomitantly with ACT-1004-1239. Receives: Drug: ACT-1004-1239 (10 mg); Drug: Itraconazole (200 mg, o.d.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (PK) parameter for plasma ACT-1004-1239: Cmax
Measured: Blood samples for PK analysis will be taken prior to study treatment administration and at multiple timepoints from Day 1 to Day 6 (Treatment period A) and from Day 9 to Day 14 (Treatment period B2; total duration: 12 days).
Secondary outcomes (3)
Pharmacokinetic parameters for plasma ACT-1004-1239: tmax
Measured: Blood samples for PK analysis will be taken prior to study treatment administration and at multiple timepoints from Day 1 to Day 6 (Treatment period A) and from Day 9 to Day 14 (Treatment period B2; total duration: 12 days).
Pharmacokinetic parameters for plasma ACT-1004-1239: AUC0-inf
Measured: Blood samples for PK analysis will be taken prior to study treatment administration and at multiple timepoints from Day 1 to Day 6 (Treatment period A) and from Day 9 to Day 14 (Treatment period B2; total duration: 12 days).
Pharmacokinetic parameters for plasma ACT-1004-1239: t1/2
Measured: Blood samples for PK analysis will be taken prior to study treatment administration and at multiple timepoints from Day 1 to Day 6 (Treatment period A) and from Day 9 to Day 14 (Treatment period B2; total duration: 12 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start1 Oct 2022
- Primary completion20 Oct 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, fixed-sequence, drug-drug interaction (DDI) study
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549531
- Sponsor's protocol ID
- ID-086-103
- Status last verified
- Nov 2022
- First submitted
- 19 Sep 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huynh C, Dingemanse J, Meyer Zu Schwabedissen HE, Fonseca M, Sidharta PN. The effect of itraconazole, a strong CYP3A4 inhibitor, on the pharmacokinetics of the first-in-class ACKR3/CXCR7 antagonist, ACT-1004-1239. Clin Transl Sci. 2024 Jul;17(7):e13883. doi: 10.1111/cts.13883.
PubMed 39010703
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Fixed-sequence Study to Investigate the Effect of Multiple-dose Itraconazole on the Pharmacokinetics of a Single Dose of 10 mg ACT-1004-1239 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05549531
- Acronym / sponsor ID
- ID-086-103
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 22 Sep 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.
A study to investigate the effect of itraconazole on the way the body absorbs, distributes, and gets rid of ACT-1004-1239 given as a single dose of 10 mg to healthy male subjects
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, fixed-sequence, drug-drug interaction (DDI) study
| Arm | Type | Receives |
|---|---|---|
| Investigational and interaction treatment | Experimental | Drug: ACT-1004-1239 (10 mg), Drug: Itraconazole (200 mg, o.d.)ACT-1004-1239 (10 mg) will be administered on Day 1 (in Treatment A) and Day 9 (in Treatment B2). Itraconazole (200 mg, o.d.) will be administered from Day 6 until Day 13. On Day 9, itraconazole will be administered concomitantly with ACT-1004-1239. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
- Healthy male subject aged between 18 and 55 years (inclusive) at Screening.
- Negative SARS-CoV-2 test or valid EU Digital COVID-19 Recovery Certificate prior to Day -1.
- A male subject with a partner of childbearing potential must use adequate contraception (i.e., condom) from first study treatment administration up to at least 30 days after EOS or premature study discontinuation (i.e., safety follow-up).
Key exclusion criteria (13 listed)
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- Participation in a clinical study involving study treatment administration within 12 weeks prior to Screening or in more than 2 clinical studies within 1 year prior to Screening.
- History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to Screening.
- Previous treatment with any prescribed medications (including vaccines such as COVID-19 vaccine) or OTC medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 3 weeks prior to first study treatment administration.
- Positive results from urine drug and alcohol screen at Screening, on Day -1.
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 |
|---|---|---|
| ACT-1004-1239 (10 mg)ACT-1004-1239 will be administered as 1 capsule of 10 mg strength to be taken under fed conditions. | Drug | Investigational and interaction treatment |
| Itraconazole (200 mg, o.d.)Itraconazole 200 mg will be administered as capsules (2 x 100 mg capsule) to be taken under fed conditions. | Drug | Investigational and interaction treatment |
Primary outcome
Pharmacokinetic (PK) parameter for plasma ACT-1004-1239: Cmax
Time frame: Blood samples for PK analysis will be taken prior to study treatment administration and at multiple timepoints from Day 1 to Day 6 (Treatment period A) and from Day 9 to Day 14 (Treatment period B2; total duration: 12 days).
3 secondary outcomes
Pharmacokinetic parameters for plasma ACT-1004-1239: tmax
Time frame: Blood samples for PK analysis will be taken prior to study treatment administration and at multiple timepoints from Day 1 to Day 6 (Treatment period A) and from Day 9 to Day 14 (Treatment period B2; total duration: 12 days).
Pharmacokinetic parameters for plasma ACT-1004-1239: AUC0-inf
Time frame: Blood samples for PK analysis will be taken prior to study treatment administration and at multiple timepoints from Day 1 to Day 6 (Treatment period A) and from Day 9 to Day 14 (Treatment period B2; total duration: 12 days).
Pharmacokinetic parameters for plasma ACT-1004-1239: t1/2
Time frame: Blood samples for PK analysis will be taken prior to study treatment administration and at multiple timepoints from Day 1 to Day 6 (Treatment period A) and from Day 9 to Day 14 (Treatment period B2; total duration: 12 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 8 Nov 2022.
- Derived from this study: PubMed 39010703Huynh C, Dingemanse J, Meyer Zu Schwabedissen HE, Fonseca M, Sidharta PN. The effect of itraconazole, a strong CYP3A4 inhibitor, on the pharmacokinetics of the first-in-class ACKR3/CXCR7 antagonist, ACT-1004-1239. Clin Transl Sci. 2024 Jul;17(7):e13883. doi: 10.1111/cts.13883.
- 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.
Clinical Trials study director
Idorsia Pharmaceuticals Ltd.
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 ACT-1004-1239 (10 mg) and Itraconazole (200 mg, o.d.) in people with Healthy, run by Idorsia Pharmaceuticals Ltd. at 1 site in Portugal.
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 13 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 8 Nov 2022. 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 Portugal. 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?
Pharmacokinetic (PK) parameter for plasma ACT-1004-1239: Cmax (time frame: Blood samples for PK analysis will be taken prior to study treatment administration and at multiple timepoints from Day 1 to Day 6 (Treatment period A) and from Day 9 to Day 14 (Treatment period B2; total duration: 12 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05549531, which also lists 1 linked publication.
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 8 Nov 2022.