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

NCT ID: NCT05549531

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2022-10-20

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

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ACT-1004-1239 (10 mg)

Intervention Type: DRUG

ACT-1004-1239 will be administered as 1 capsule of 10 mg strength to be taken under fed conditions.

Itraconazole (200 mg, o.d.)

Intervention Type: DRUG

Itraconazole 200 mg will be administered as capsules (2 x 100 mg capsule) to be taken under fed conditions.

Interventions

ACT-1004-1239 (10 mg)

ACT-1004-1239 will be administered as 1 capsule of 10 mg strength to be taken under fed conditions.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Idorsia Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Idorsia Pharmaceuticals Ltd.

Locations

BlueClinical Phase 1

Porto, , Portugal

Countries

Portugal

References

Huynh C, Dingemanse J, Meyer Zu Schwabedissen HE, Fonseca M, Sidharta PN. The effect of itraconazole, a strong CYP3A4 inhibitor, on the pharmacokinetics of the first-in-class ACKR3/CXCR7 antagonist, ACT-1004-1239. Clin Transl Sci. 2024 Jul;17(7):e13883. doi: 10.1111/cts.13883.

Reference Type: DERIVED

PMID: 39010703 (View on PubMed)

Other Identifiers

ID-086-103

Identifier Type: -

Identifier Source: org_study_id