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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03103646
Enrollment
22
Registered
2017-04-06
Start date
2017-03-28
Completion date
2019-07-19
Last updated
2019-10-02

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

Conditions

Cytochrome P450 Interaction

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.

Interventions

DRUGLu AF35700

Tablets for oral use, single dose in a fasted state. EMs: 10 mg/day, PMs: 5 mg

DRUGItraconazole (200 mg)

100 mg Capsules for oral use, 200 mg/day. In a fed state

DRUGItraconazole (300 mg)

100mg Capsules for oral use, 300 mg/day. In a fasted state.

Sponsors

H. Lundbeck A/S
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

Inclusion criteria

* 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

Exclusion criteria

* Pregnant or lactating * Subject has previously been dosed with Lu AF35700 Other protocol defined inclusion and

Design outcomes

Primary

MeasureTime frameDescription
AUC(0-inf)Day 1: Predose to day 29 postdose, Day 32: Predose to day 74 postdoseArea under the Lu AF35700 plasma concentration-time curve (with and without itraconazole) for CYP2D6 EMs
Cmax0-24 hours postdose (Day 1 and day 32)Maximum observed plasma concentration of Lu AF35700 (with and without itraconazole) for CYP2D6 EMs

Countries

United Kingdom, United States

Outcome results

None listed

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