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 Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Investigational and interaction treatment 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)
ACT-1004-1239 will be administered as 1 capsule of 10 mg strength to be taken under fed conditions.
Drug: Itraconazole (200 mg, o.d.)
Itraconazole 200 mg will be administered as capsules (2 x 100 mg capsule) to be taken under fed conditions.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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).]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
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Healthy male subject aged between 18 and 55 years (inclusive) at Screening.
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Negative SARS-CoV-2 test or valid EU Digital COVID-19 Recovery Certificate prior to Day -1.
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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:
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Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
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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.
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History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to Screening.
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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.
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Positive results from urine drug and alcohol screen at Screening, on Day -1.
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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.
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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.
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Any immunosuppressive treatment within 6 weeks or 5 x t½, whichever is longer, before first study treatment administration.
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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.
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Baseline QTc interval >450 ms or <350 ms at Screening or on Day -1.
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Alanine aminotransferase, aspartate aminotransferase, or creatinine kinase values above the upper limit of the normal range at Screening.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | BlueClinical Phase 1 | Porto | Portugal | 4250-449 |
Sponsors and Collaborators
- Idorsia Pharmaceuticals Ltd.
Investigators
- Study Director: Clinical Trials, Idorsia Pharmaceuticals Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ID-086-103