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
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started May 2020
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 20, 2020
CompletedFirst Submitted
Initial submission to the registry
May 22, 2020
CompletedFirst Posted
Study publicly available on registry
May 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 28, 2020
CompletedAugust 14, 2020
August 1, 2020
2 months
May 22, 2020
August 13, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
AUC(0-inf) Lu AG06466
Area under the Lu AG06466 plasma concentration-time curve from time zero to infinity
From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
AUC(0-inf) Lu AG06988
Area under the Lu AG06988 plasma concentration-time curve from time zero to infinity
From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
Cmax Lu AG06466
Maximum observed plasma concentration (Cmax) of Lu AG06466
From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
Cmax Lu AG06988
Maximum observed plasma concentration (Cmax) of Lu AG06988
From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
Study Arms (2)
Lu AG06466 - Sequence 1
EXPERIMENTALDosing on Days 1 and 8 will be following an overnight fast, and dosing on Days 3 and 10 will be following a standard high-fat breakfast.
Lu AG06466 - Sequence 2
EXPERIMENTALDosing on Days 1 and 8 will be following, a standard high-fat breakfast and dosing on Days 3 and 10 will be following an overnight fast.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- The subject is a poor metabolizer (PM) of CYP2C9 and/or CYP2C19.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (1)
US1517
Miami, Florida, 33126, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@Lundbeck.com
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2020
First Posted
May 28, 2020
Study Start
May 20, 2020
Primary Completion
July 28, 2020
Study Completion
July 28, 2020
Last Updated
August 14, 2020
Record last verified: 2020-08