Study Evaluating the Effect of Multiple Doses of Itraconazole on the Drug Lu AF35700 in Healthy Young Men and Women
Interventional, Open-label, One-sequence Crossover Study Evaluating the Effect of Multiple Doses of Itraconazole (Inhibitor of CYP3A4/5) on the Pharmacokinetics, Safety and Tolerability of Lu AF35700 in Healthy Young Men and Women
2 other identifiers
interventional
22
2 countries
2
Brief Summary
This study will investigate the effect of multiple doses of the strong P450 enzyme inhibitor itraconazole on the pharmacokinetics of Lu AF35700 in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2017
Typical duration for phase_1
2 active sites
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
March 28, 2017
CompletedFirst Submitted
Initial submission to the registry
March 31, 2017
CompletedFirst Posted
Study publicly available on registry
April 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 19, 2019
CompletedOctober 2, 2019
October 1, 2019
2 years
March 31, 2017
October 1, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
AUC(0-inf)
Area under the Lu AF35700 plasma concentration-time curve (with and without itraconazole) for CYP2D6 EMs
Day 1: Predose to day 29 postdose, Day 32: Predose to day 74 postdose
Cmax
Maximum observed plasma concentration of Lu AF35700 (with and without itraconazole) for CYP2D6 EMs
0-24 hours postdose (Day 1 and day 32)
Study Arms (2)
Lu AF35700
EXPERIMENTALDay 1: Single dose of Lu AF35700. Extensive metabolisers (EMs): 10mg. Poor metabolisers (PMs): 5 mg
Lu AF35700 AND itraconazole
EXPERIMENTALDays 29 to 31: once-daily dosage of 200 mg itraconazole. Day 32: Single dose of Lu AF35700 (EMs: 10 mg, PMs: 5 mg) and 300 mg itraconazole Days 33 to 42: once-daily dosage of 200 mg itraconazole
Interventions
Tablets for oral use, single dose in a fasted state. EMs: 10 mg/day, PMs: 5 mg
100 mg Capsules for oral use, 200 mg/day. In a fed state
100mg Capsules for oral use, 300 mg/day. In a fasted state.
Eligibility Criteria
You may qualify if:
- Men, aged ≥18 and ≤55 years. body weight ≥50 kg
- women, aged ≥18 and ≤45 years, body weight ≥50 kg
- Good general health as assessed using detailed medical history, laboratory tests, and physical examination
- Known CYP2D6 and CYP2C19 genotype
You may not qualify if:
- Pregnant or lactating
- Subject has previously been dosed with Lu AF35700
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (2)
Covance - Dallas
Dallas, Texas, 75247, United States
Covance Clinical Research Unit Ltd
Leeds, United Kingdom
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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2017
First Posted
April 6, 2017
Study Start
March 28, 2017
Primary Completion
April 14, 2019
Study Completion
July 19, 2019
Last Updated
October 2, 2019
Record last verified: 2019-10