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Completed

NCT Number: NCT03670082

Study With Lu AF35700 in Healthy Men and Women in Fasting and Fed State

The purpose of this study is to investigate the extent to which Lu AF35700 enters the bloodstream following pill intake and the influence of food on the uptake in healthy men and women

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance

Leeds, United Kingdom

About this study

Each subject will receive a single oral dose of Lu AF35700 on Day 1 in each Period. Subjects in Group 1 will be in fasting condition in Period I and in a fed condition in Period II. Subjects in Group 2 will be in fed condition in Period I and in fasting condition in Period II.

For Group 1, period 1 only, a single intravenous micro-dose of Lu AF35700 will be given 4 hours after oral dosing.

All subjects will be confined to the clinic from one day prior to the first dosing until Day 6 (120 hours post dose) for each dosing period. Periods I and II will be separated by a period of 6 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy men and women aged ≥18 and ≤55 years
  • Body Mass Index (BMI) of ≥18.5 and ≤30 kg/m2
  • Subject must be in good general health as assessed using medical history, clinical laboratory tests, and physical examination

Exclusion criteria

  • The subject must not be of childbearing potential (if a woman) or should use contraception, be surgically sterilized or not be sexually active (both sexes). Women must not be pregnant or lactating
  • The subject must not be a CYP2D6 or a CYP2C19 poor metabolizer

Other inclusion and exclusion criteria may apply.

Treatment and study plan

Lu AF35700

Drug

20 mg Lu AF35700 single oral dose

Lu AF35700 iv

Drug

100 μg [14C]-Lu AF35700 (4.7 μCi/174 kBq) single intravenous micro-dose

Primary outcomes

  1. Absolute bioavailability Fabs

    Time frame: 0 to 120 hours

    Fabs= 100*(AUC0-72h, po*Div) / (AUC0-72h, iv*Dpo) (where D is the dose)

Secondary outcomes

  1. AUC0-inf: area under the Lu AF35700 plasma concentration-time curve from zero to 72 hours

    Time frame: 0 to 120 hours

    Area under the plasma concentration-time curve from zero to 72 hours for Lu AF35700

  2. Cmax: maximum observed plasma concentration

    Time frame: 0 to 120 hours

    Maximum observed plasma concentration of Lu AF35700

  3. tmax: time at maximum observed plasma concentration

    Time frame: 0 to 120 hours

    Time at which maximum observed plasma concentration of Lu AF35700 occurred

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

Interventional, Open-label, Two-way Crossover, Single-dose Study Investigating the Absolute Bioavailability and Food Effect on the Pharmacokinetics of Lu AF35700 in Healthy Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Sep 13, 2018
Registry last updated
Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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