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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04405323
Enrollment
16
Registered
2020-05-28
Start date
2020-05-20
Completion date
2020-07-28
Last updated
2020-08-14

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

Conditions

Healthy

Brief summary

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.

Detailed description

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.

Interventions

DRUGLu AG06466

hard capsules, orally, single doses

DRUGItraconazole

200 and 300 mg, capsules, orally

Sponsors

H. Lundbeck A/S
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
AUC(0-inf) Lu AG06466From 0 to 48 hours post-dose on Day 1, 3, 8 and 10Area under the Lu AG06466 plasma concentration-time curve from time zero to infinity
AUC(0-inf) Lu AG06988From 0 to 48 hours post-dose on Day 1, 3, 8 and 10Area under the Lu AG06988 plasma concentration-time curve from time zero to infinity
Cmax Lu AG06466From 0 to 48 hours post-dose on Day 1, 3, 8 and 10Maximum observed plasma concentration (Cmax) of Lu AG06466
Cmax Lu AG06988From 0 to 48 hours post-dose on Day 1, 3, 8 and 10Maximum observed plasma concentration (Cmax) of Lu AG06988

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026