Healthy
Conditions
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
Interventions
DRUGACT-1004-1239 (10 mg)
ACT-1004-1239 will be administered as 1 capsule of 10 mg strength to be taken under fed conditions.
DRUGItraconazole (200 mg, o.d.)
Itraconazole 200 mg will be administered as capsules (2 x 100 mg capsule) to be taken under fed conditions.
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Open-label, fixed-sequence, drug-drug interaction (DDI) study
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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). |
Countries
Portugal
Outcome results
None listed