NCT03019549

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

January 12, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2017

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

April 16, 2019

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

4 months

First QC Date

January 11, 2017

Results QC Date

December 13, 2018

Last Update Submit

October 18, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve From Zero to Infinity (AUC-∞) of Rosuvastatin

    Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve from Zero to Infinity (AUC-∞) of Rosuvastatin

    1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose

Secondary Outcomes (2)

  • Pharmacokinetics (PK): Area Under the Drug Concentration Time Curve During a 24-hour Dosing Interval (AUCτ) of Lanabecestat (LY3314814)

    Period 2 (Day 7, 8): Predose, 0.5, 1, 2, 3, 4, 8, 12 hours postdose

  • Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lanabecestat

    .Period 2 (Day 7, 8): Predose, 0.5, 1, 2, 3, 4, 8, 12 hours postdose

Study Arms (2)

Rosuvastatin

EXPERIMENTAL

Period 1: 20 mg rosuvastatin administered once orally (PO)

Drug: Rosuvastatin

Lanabecestat + Rosuvastatin

EXPERIMENTAL

Period 2: 50 mg Lanabecestat (LY3314814) administered orally (PO) Day 1 to Day 12 Rosuvastatin: 20 mg co-administered PO on Day 8

Drug: LanabecestatDrug: Rosuvastatin

Interventions

LanabecestatDRUG

Administered orally

Also known as: LY3314814, AZD3293
Lanabecestat + Rosuvastatin
RosuvastatinDRUG

Administered orally

Lanabecestat + RosuvastatinRosuvastatin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- Have a clinically significant abnormal blood pressure or heart rate (supine) as determined by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Inc

Daytona Beach, Florida, 32117, United States

Location

Related Links

MeSH Terms

Interventions

lanabecestatRosuvastatin Calcium

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

11 participants completed Period 1 and then discontinued due to genotyping criteria.

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Compnay
Clinicaltrials.gov@lilly.com
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 12, 2017

Study Start

January 12, 2017

Primary Completion

May 22, 2017

Study Completion

May 22, 2017

Last Updated

November 1, 2019

Results First Posted

April 16, 2019

Record last verified: 2019-10

Locations

US(1)