Effects of Repeated Doses of Lu AF35700 on Drug Metabolizing Enzymes

Phase 1CompletedNCT03195946

H. Lundbeck A/S24 enrolled

Overview

This study will help determine which types of drugs that may interact with Lu AF35700

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Drug Reactions

Interventions

Lu AF35700DRUG

tablets for oral use, 10 mg/day

MidazolamDRUG

syrup for oral use, 4mg/day

Cocktail of CYP450 substratesDRUG

Caffeine tablets for oral use, 200 mg/day. Omeprazole tablets for oral use, 40 mg/day. Dextromethorphan tablets for oral use, 30 mg/day. Midazolam IV solution for Intravenous use, 0.025 mg/kg/day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Body weight at least 50 kg and Body Mass Index 19 - 30 kg/m2 * Good general health ascertained by a detailed medical history, laboratory tests and physical examination Exclusion Criteria: -Pregnant or lactating women Other protocol defined inclusion and exclusion criteria may apply

Locations (1)

Covance Clinical Research Unit Ltd

Leeds, United Kingdom

Outcomes

Primary Outcomes

AUC(0-inf): Area under the plasma concentration-time curve from zero to infinity

Area under the plasma concentration-time curve from zero to infinity for oral midazolam and metabolite and all drug cocktail components and their metabolites

Time frame: Up to 24 hours post dose on the following days: Day 1 and 27 for oral midazolam. Day 2 and 28 for cocktail components.

Cmax: Maximum observed concentration

Maximum observed concentration of oral midazolam and all drug cocktail components and their metabolites

Time frame: Up to 24 hours post dose on the following days: Day 1 and 27 for oral midazolam. Day 2 and 28 for Cocktail components.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.