This study is to check the Drug-drug interaction of LXE408 with itraconazole and phenytoin

A Phase I, open-label, single-sequence, two-part, two-period, drug-drug interaction study to assess the effect of itraconazole and phenytoin on the pharmacokinetics of a single oral dose of LXE408 in healthy participants - NIL

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/087526

Enrollment

Registered

2025-05-23

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: LXE408: Single 50mg oral dose on day 1 Intervention2: Itraconazole: 200 mg itraconazole once daily from Day 7 to Day 20 with breakfast except on Day 10 when LXE408 is given concomitan

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects willing to adhere to the protocol requirements and to provide written informed consent prior to participation in the study. 2.Healthy male or non-childbearing potential female participants 18 to 55 years of age inclusive at screening. 3.In good health as determined by no clinically significant findings from past medical history, physical examination, vital signs, chest X-rays, 2D-ECHO, ECG, and clinical laboratory tests during screening and/or baseline. 4.Participants must weigh at least 50.0 kg with a body mass index (BMI) within the range of 18.0 to 29.9 kg/m2, inclusive, at screening. 5.At screening and baseline, vital signs (systolic and diastolic blood pressure, body temperature and pulse rate) will be assessed in the sitting position and again (when required) in the standing position. Vital signs after sitting 3 minutes in a quiet environment must be within the following ranges: oral body temperature between 35.0-37.5Â°C, systolic blood pressure between 90-139 mm Hg, diastolic blood pressure between 50-89 mm Hg, and pulse rate between 50-100 bpm.

Exclusion criteria

Exclusion criteria: 1.History or current diagnosis of ECG or cardiac abnormalities indicating significant risk of safety for participants. 2.Participants who have received other investigational drugs within 5 half-lives or within 30 days or until the expected pharmacodynamic effect has returned to baseline prior to initial dosing, whichever is longer. 3.History of hypersensitivity to the investigational compounds (LXE408, Itraconazole or Phenytoin)/compound class or excipients being used in this study 4.Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 30 days after stopping study treatment. 5.Any single parameter of alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), or alkaline phosphatase (ALP) exceeding 1.2 Ã? upper limit of normal (ULN) and >= 1.5 Ã? ULN total bilirubin OR any elevation above ULN of more than one parameter of ALT, AST, GGT, ALP, or serum bilirubin at screening 6.Any single parameter of amylase or lipase above 1.0 x ULN, or any history or presence of clinical symptoms suggestive of pancreatitis. 7.History or presence of impaired renal function as indicated by clinically significantly abnormal creatinine (creatinine level above 1.5x ULN) or blood urea, or abnormal urinary constituents (e.g. proteinuria, microscopy confirmed hematuria) at screening.

Design outcomes

Primary

Measure	Time frame
To investigate the effect of multiple doses of CYP3A inhibitor, itraconazole, at 200 mg QD on the PK of a single 50 mg oral dose of LXE408 in healthy participants. To investigate the effect of multiple doses of CYP3A inducer, phenytoin, at 100 mg TID on the PK of a single 50 mg oral dose of LXE408 in healthy participants Timepoint: Primary PK parameters of LXE408 in plasma such as AUClast, AUCinf, AUC0-t (as appropriate), Cmax and Tmax. Secondary plasma PK parameters of LXE408 including AUC0-24, CL/F, Vz/F and T1/2 as feasible. [Part 1 & Part 2 in Period 1: From dose (0h) up to 120h. Part 1 in Period 2: From Pre-dose (0h) up to 264h. Part 2 in Period 2: From Pre-dose (0h) up to 120h.]	—

Measure

Time frame

To investigate the effect of multiple doses of CYP3A inhibitor, itraconazole, at 200 mg QD on the PK of a single 50 mg oral dose of LXE408 in healthy participants. To investigate the effect of multiple doses of CYP3A inducer, phenytoin, at 100 mg TID on the PK of a single 50 mg oral dose of LXE408 in healthy participants Timepoint: Primary PK parameters of LXE408 in plasma such as AUClast, AUCinf, AUC0-t (as appropriate), Cmax and Tmax. Secondary plasma PK parameters of LXE408 including AUC0-24, CL/F, Vz/F and T1/2 as feasible. [Part 1 & Part 2 in Period 1: From dose (0h) up to 120h. Part 1 in Period 2: From Pre-dose (0h) up to 264h. Part 2 in Period 2: From Pre-dose (0h) up to 120h.]

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Secondary

Measure	Time frame
To assess the safety & tolerability of a single 50 mg oral dose of LXE408 given alone & with multiple doses of itraconazole at 200 mg QD in healthy participants. To assess the safety & tolerability of a single 50 mg oral dose of LXE408 given alone & with multiple 100 mg doses of phenytoin TID in healthy participants.Timepoint: All safety endpoints including vital signs, ECG, clinical laboratory evaluation & AEs [from Screening to End of Study]	—

Measure

Time frame

To assess the safety & tolerability of a single 50 mg oral dose of LXE408 given alone & with multiple doses of itraconazole at 200 mg QD in healthy participants. To assess the safety & tolerability of a single 50 mg oral dose of LXE408 given alone & with multiple 100 mg doses of phenytoin TID in healthy participants.Timepoint: All safety endpoints including vital signs, ECG, clinical laboratory evaluation & AEs [from Screening to End of Study]

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Countries

India

Contacts

Public ContactMurugananthan K

Novartis Healthcare Private Limited

murugananthan.k@novartis.com912250243544

Outcome results