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OpenTrials
Completed

NCT Number: NCT04405323

Study That Evaluates the Effect of CYP3A4 Inhibition on Lu AG06466 in Healthy Men and Women

A study to learn how a drug (itraconazole) that is known to inhibit a certain enzym in the liver, impacts the body's ability to breakdown Lu AG06466 into breakdown products in healthy men and women. The main breakdown product is Lu AG06988.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

US1517

Miami, Florida, 33126, United States

About this study

Two sequence study where Lu AG06466 will be dosed with and without food, Sequence 1 and Sequence 2. Each subject will receive single oral doses of Lu AG06466. Subject will be randomized to one of two sequences.

For inhibition of CYP3A4, each subject will receive a once daily dosage of itraconazole from Day 5 to Day 11.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subject has a BMI ≥18.5 and ≤30 kg/m2
  • The subject is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, a neurological examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.
  • The subject must not be of childbearing potential (if a woman) or should use contraception (both sexes). If women, the subject must not be pregnant or breastfeeding.

Exclusion criteria

  • The subject is a poor metabolizer (PM) of CYP2C9 and/or CYP2C19.

Other in- and exclusion criteria may apply

Treatment and study plan

Lu AG06466

Drug

hard capsules, orally, single doses

Itraconazole

Drug

200 and 300 mg, capsules, orally

Primary outcomes

  1. AUC(0-inf) Lu AG06466

    Time frame: From 0 to 48 hours post-dose on Day 1, 3, 8 and 10

    Area under the Lu AG06466 plasma concentration-time curve from time zero to infinity

  2. AUC(0-inf) Lu AG06988

    Time frame: From 0 to 48 hours post-dose on Day 1, 3, 8 and 10

    Area under the Lu AG06988 plasma concentration-time curve from time zero to infinity

  3. Cmax Lu AG06466

    Time frame: From 0 to 48 hours post-dose on Day 1, 3, 8 and 10

    Maximum observed plasma concentration (Cmax) of Lu AG06466

  4. Cmax Lu AG06988

    Time frame: From 0 to 48 hours post-dose on Day 1, 3, 8 and 10

    Maximum observed plasma concentration (Cmax) of Lu AG06988

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

Interventional, Open-label, Randomized, Two-sequence Study Evaluating the Effect of CYP3A4 Inhibition on the Pharmacokinetics, Safety and Tolerability of Lu AG06466 in Healthy Men and Women

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 28, 2020
Registry last updated
Aug 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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