- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04405323
Study That Evaluates the Effect of CYP3A4 Inhibition on Lu AG06466 in Healthy Men and Women
August 13, 2020 updated by: H. Lundbeck A/S
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
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33126
- US1517
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lu AG06466 - Sequence 1
Dosing 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.
|
hard capsules, orally, single doses
200 and 300 mg, capsules, orally
|
Experimental: Lu AG06466 - Sequence 2
Dosing 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.
|
hard capsules, orally, single doses
200 and 300 mg, capsules, orally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
|
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
|
From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
|
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
|
From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
|
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
|
From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 20, 2020
Primary Completion (Actual)
July 28, 2020
Study Completion (Actual)
July 28, 2020
Study Registration Dates
First Submitted
May 22, 2020
First Submitted That Met QC Criteria
May 22, 2020
First Posted (Actual)
May 28, 2020
Study Record Updates
Last Update Posted (Actual)
August 14, 2020
Last Update Submitted That Met QC Criteria
August 13, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Itraconazole
Other Study ID Numbers
- 18453A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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