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 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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: ACT-1004-1239 (10 mg); Drug: Itraconazole (200 mg, o.d.)

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4250-449
    • BlueClinical Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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).

Collaborators and Investigators

• Sponsor: Idorsia Pharmaceuticals Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): October 20, 2022
• Study Completion (Actual): October 20, 2022

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Itraconazole
• Other Study ID Numbers: ID-086-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No