A Drug-Drug Interaction Study to Assess the CYP1A2 and CYP3A4 Interaction Potential of TEV-56286 (anle138b)

Modag

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Fluvoxamine 100 mg QD for 5 days

Drug: anle138b (TEV-56286)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05532358

2022-002467-30 (EudraCT Number)

anle138b-P1-03

Details and patient eligibility

About

The purpose of this healthy volunteers drug-drug interaction study is to assess the CYP1A2 and CYP3A4 perpetrator interaction potential and CYP1A2 victim potential of TEV-56286 (anle138b).

Full description

This a 2-part DDI study that will assess the CYP1A2 and CYP3A4 perpetrator interaction potential of TEV-56286 single dose and multiple dose, using caffeine and midazolam as substrates and CYP1A2 victim potential of TEV-56286 (anle138b) at steady state induction using fluvoxamine as inhibitor [1,2].The estimated time from screening until the follow-up visit is approximately up to 8 weeks for each subjects.

Enrollment

54 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy males or healthy females of non-childbearing potential
Must provide written informed consent for participation in the study and must be able to understand the study requirements
Body mass index (BMI) 18.5 to 32.0 kg/m2.
Must agree to adhere to the contraception requirements defined in the study protocol.

Exclusion criteria

Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients e.g. fluvoxamine, caffeine, midazolam or benzodiazepines or any of its excipients, or a known drug hypersensitivity idiosyncratic reaction to TEV-56286, or one of its excipients
History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, metabolic diseases or a history of any illness that, in the opinion of the investigator, might pose additional risk to the subject by participation in the study or confound the results of the study
Acute infection and/or antibiotic treatment within 28 days of Day 1
Major trauma or surgery in the 2 months before screening or at any time between screening and Day 1, or surgery scheduled during the study or follow up period
History of malignancy or treatment of malignancy in the last 5 years
History of suicidal ideation with an intent and/or plan and behaviour based upon either clinical history or source documents
Personal or family history of arrhythmia, sudden unexplained death at a young age (before 40 years) in a first-degree relative, or long QT syndrome, or a personal history of syncope or previous treatment for high blood pressure (BP). Abnormality of 12-lead ECG that may, in the opinion of the investigator, interfere with study participation
Any procedure or disorder that may interfere with drug absorption, distribution, metabolism, or excretion
Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator.
Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer
Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies in the 14 days before study medication administration or within 5 half-lives whichever is longer.
Subjects who are taking, or have taken hormonal contraceptives (e.g., oral, patch, injectable or intrauterine device) hormone replacement therapy (HRT) or a long-acting injectable hormonal within 4 weeks prior to first dose of IMP
Subjects who are taking, or have taken any inducer of CYP 1A2, CYP3A4 within 28 days prior to Day -2
History of any drug or alcohol abuse in the past 2 years
Current smokers and those who have smoked within the last 12 months or has a positive urine cotinine test
Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
Subjects with a previous history of difficulty in swallowing tablets or capsules, or an anticipated problem with swallowing a large number of capsules
Subjects who have consumed grapefruit, grapefruit juice, Seville oranges, pomelo-containing products, vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, brussel sprouts, and mustard) and charbroiled meats within the 14 days prior to Day -2
Subjects who are unwilling to comply with the restricted use of caffeinated beverages (e.g. coffee, tea, cola) during the study