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 Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: ACT-1004-1239 (10 mg)
* Drug: Itraconazole (200 mg, o.d.)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Open-label, fixed-sequence, drug-drug interaction (DDI) study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational and interaction treatment<br>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. | Drug: ACT-1004-1239 (10 mg)<br>* ACT-1004-1239 will be administered as 1 capsule of 10 mg strength to be taken under fed conditions.<br>Drug: Itraconazole (200 mg, o.d.)<br>* Itraconazole 200 mg will be administered as capsules (2 x 100 mg capsule) to be taken under fed conditions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic (PK) parameter for plasma ACT-1004-1239: Cmax |  | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters for plasma ACT-1004-1239: tmax |  | 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 |  | 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 |  | 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). |