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NCT05549531 | Completed | Healthy

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
Sponsor:

Idorsia Pharmaceuticals Ltd.

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

Healthy

Intervention/treatment

ACT-1004-1239 (10 mg)

Itraconazole (200 mg, o.d.)

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 16 participants
Masking : None (Open Label)
Primary Purpose : Other
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
Actual Study Start Date : October 1, 2022
Estimated Primary Completion Date : October 20, 2022
Estimated Study Completion Date : October 20, 2022
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)

Drug: Itraconazole (200 mg, o.d.)
Ages Eligible for Study: 18 Years to 55 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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.
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

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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

How to Participate

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Locations

Not yet recruiting

Portugal,

BlueClinical Phase 1

Porto, Portugal, 4250-449