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Study Evaluating the Effect of Multiple Doses of Itraconazole on the Drug Lu AF35700 in Healthy Young Men and Women

NCT03103646 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2019-10-02

No results posted yet for this study

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.

Conditions

  • Cytochrome P450 Interaction

Interventions

DRUG

Lu AF35700

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

DRUG

Itraconazole (200 mg)

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

DRUG

Itraconazole (300 mg)

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

Sponsors & Collaborators

  • H. Lundbeck A/S

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-28
Primary Completion
2019-04-14
Completion
2019-07-19

Countries

  • United States
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03103646 on ClinicalTrials.gov