Phase 1
Completed N=60
A Drug-drug Interaction Study of Lanabecestat (LY3314814) in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT02568397 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Pharmacokinetics (PK) : Maximum Concentration (Cmax) of Dabigatran — 128; 148; 138 nanogram per milliliter (ng/mL)
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK) : Maximum Concentration (Cmax) of Dabigatran |
128; 148; 138 | — |
| PRIMARY Pharmacokinetics: Area Under The Dabigatran Pharmacokinetic (PK) Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity) |
1090; 1240; 1110 | — |
| SECONDARY Pharmacokinetics: Maximum Concentration (Cmax) of Lanabecestat |
342; 315; 331 | — |
| SECONDARY Pharmacokinetics: Area Under the Lanabecestat Pharmacokinetic (PK) Concentration Versus Time Curve During One Dosing Interval (24 Hours) (AUCtau) |
3360; 3300; 3490 | — |
| SECONDARY Pharmacodynamics: Area Under the Effect Versus Time Curve (AUEC) of Thrombin Time |
2080; 2170; 2030 | — |
| SECONDARY Pharmacodynamics: Ratio of Maximum Effect to Baseline Effect (ERmax) of Thrombin Time |
7.10; 7.09; 7.00 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02568397). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.