Phase 1
Completed N=42
A Study of Lanabecestat (LY3314814) in Healthy Participants When Taken With Rosuvastatin
Healthy
Source: ClinicalTrials.gov NCT03019549 ↗
Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve From Zero to Infinity (AUC-∞) of Rosuvastatin — 80; 78 hours times nanogram per milliliter
Summary
The purpose of this study is to evaluate the effect of lanabecestat on rosuvastatin. The amount of rosuvastatin in the blood will be compared, when taken alone, and then when taken with lanabecestat. The amount of lanabecestat that gets into the bloodstream will be measured. Information about any side effects that may occur will also be collected.
Participants will be on study for 21 days with a follow-up at least 7 days afterwards.
Screening will be undertaken within 45 days prior to enrollment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve From Zero to Infinity (AUC-∞) of Rosuvastatin |
80; 78 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Drug Concentration Time Curve During a 24-hour Dosing Interval (AUCτ) of Lanabecestat (LY3314814) |
3650; 3790 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lanabecestat |
369; 399 | — |
Eligibility Criteria
Inclusion Criteria
- Women not of childbearing potential may participate and include those who are:
- Infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis; or
- Postmenopausal - defined as women over 50 years of age with an intact uterus who have not taken hormones or oral contraceptives within 1 year, who have had either Spontaneous cessation of menses for at least 12 consecutive months, or 6 to 12 months of spontaneous amenorrhea with follicle-stimulating hormone level greater than (>)40 milli-international units per millilitre (mIU/mL) consistent with menopause
- Caucasian and may be of Hispanic ethnicity
- Body mass index (BMI) of 19 to 32 kilogram per meter square (kg/m²), inclusive, at the time of screening
Exclusion Criteria
- Have a clinically significant abnormal blood pressure or heart rate (supine) as determined by the investigator
Data sourced from ClinicalTrials.gov (NCT03019549). 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.