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Completed

NCT Number: NCT03394482

Bioequivalence Study of Lu AF35700

The purpose of this study is to establish bioequivalence of Lu AF35700 between the clinical formulation and the commercial formulation for three tablet strengths; 5, 10 and 20 mg

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance

Leeds, United Kingdom

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 ≤32 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 metaboliser
  • The subject has previously been dosed with Lu AF35700

Other protocol defined inclusion and exclusion criteria may apply

Treatment and study plan

Lu AF35700 5 mg clinical formulation

Drug

Lu AF35700 tablets 5 mg oral single dose

Lu AF35700 5 mg commercial formulation

Drug

Lu AF35700 tablets 5 mg oral single dose

Lu AF35700 10 mg clinical formulation

Drug

Lu AF35700 tablets 10 mg oral single dose

Lu AF35700 10 mg commercial formulation

Drug

Lu AF35700 tablets 10 mg oral single dose

Lu AF35700 20 mg clinical formulation

Drug

Lu AF35700 tablets 20 mg oral single dose

Lu AF35700 20 mg commercial formulation

Drug

Lu AF35700 tablets 20 mg oral single dose

Primary outcomes

  1. AUC0-72h of Lu AF35700

    Time frame: zero to 72 hours

    Area under the Lu AF35700 plasma concentration-time curve from zero to 72 hours post-dose (AUC0-72h)

  2. Cmax of Lu AF35700

    Time frame: zero to 72 hours

    Maximum observed plasma concentration (Cmax) of Lu AF35700

Secondary outcomes

  1. Tmax of Lu AF35700

    Time frame: zero to 72 hours

    Time to occurance of Cmax of Lu AF35700

  2. AUC0-t of Lu AF35700

    Time frame: zero to time of the last quantifiable plasma concentration

    Area under the Lu AF35700 concentration-time curve from zero to time of the last quantifiable plasma concentration

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

Interventional, Randomized, Open-label, Three-group, Two-sequence Crossover, Single-dose, Bioequivalence Study of Lu AF35700 in Healthy Subjects Comparing the 5, 10 and 20 mg Commercial Tablet (Test) to the 5, 10 and 20 mg Clinical Tablet (Reference)

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 9, 2018
Registry last updated
Nov 29, 2018

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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