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OpenTrials
Completed

NCT Number: NCT02568397

A Drug-drug Interaction Study of Lanabecestat (LY3314814) in Healthy Participants

The purpose of this study is to learn about the effect of lanabecestat on how the body absorbs and processes dabigatran etexilate and how dabigatran etexilate affects lanabecestat when they are taken together. This study will last about 28 days and participants will be asked to take an lanabecestat tablet daily for 19 days and a dabigatran etexilate tablet on 3 occasions. Screening is required within 30 days prior to the start of the study.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Overtly healthy males and females

Exclusion criteria

  • Eye abnormalities or disease
  • History of vitiligo or any skin color disorder
  • Have a history psychiatric or brain disease including seizures
  • Have smoked within the last 3 months
  • Are unwilling to avoid food and drinks containing grapefruit or Seville oranges for the duration of the study
  • Have known allergies to dabigatran etexilate and related compounds

Treatment and study plan

Lanabecestat

Drug

Administered orally

Other names: LY3314814, AZD3293

Dabigatran Etexilate

Drug

Administered orally

Primary outcomes

  1. Pharmacokinetics (PK) : Maximum Concentration (Cmax) of Dabigatran

    Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose

  2. Pharmacokinetics: Area Under The Dabigatran Pharmacokinetic (PK) Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity)

    Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose

Secondary outcomes

  1. Pharmacokinetics: Maximum Concentration (Cmax) of Lanabecestat

    Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose

  2. Pharmacokinetics: Area Under the Lanabecestat Pharmacokinetic (PK) Concentration Versus Time Curve During One Dosing Interval (24 Hours) (AUCtau)

    Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose

  3. Pharmacodynamics: Area Under the Effect Versus Time Curve (AUEC) of Thrombin Time

    Time frame: Days 1, 16 and 20: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose

  4. Pharmacodynamics: Ratio of Maximum Effect to Baseline Effect (ERmax) of Thrombin Time

    Time frame: Days 1, 16 and 20: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose

    Ratio of maximum effect to baseline effect following administration of 150 mg dabigatran etexilate alone on Day 1, 50 mg LY3314814 and 150 mg dabigatran dosed concurrently on Day 16, and 50 mg LY3314814 and 150 mg dabigatran (dosed 4 hours later) on Day 20

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

Effect of LY3314814 on the Pharmacokinetics of Dabigatran in Healthy Subjects

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 5, 2015
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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