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NCT03222427

A Study of LY3314814 in Healthy Participants

Completed Phase 1 Results posted Last updated 31 October 2019
What this trial tests

Phase 1 trial testing LY3314814 in Healthy in 8 participants. Completed in 16 February 2018.

Timeline
15 January 2018
Primary endpoint
16 February 2018
16 February 2018

Quick facts

Lead sponsorAstraZeneca
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposebasic science
Enrollment8
Start date15 January 2018
Primary completion16 February 2018
Estimated completion16 February 2018
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Absolute Bioavailability of LY3314814 Primary · Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose

Absolute bioavailability was quantified using a mixed-effects analysis of variance (ANOVA) model applied to the log-transformed dose-normalized AUC(0-∞) of LY3314814 oral dosing and IV administered \[13C415N3\]-LY3314814.

GroupValue95% CI
LY331481460.5± 41
[13C415N3] LY331481459.2± 17
Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY3314814 and [13C415N3] LY3314814 Secondary · Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose

Pharmacokinetics: Area Under the Drug Concentration-Time Curve from Zero to Infinity (AUC\[0 ∞\]) of LY3314814 and \[13C415N3\] LY3314814

GroupValue95% CI
LY33148143020± 41
[13C415N3] LY33148145.92± 17

Adverse events — posted to ClinicalTrials.gov

Time frame: From baseline to end of study (Up To 7 days). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

LY3314814 + [13C415N3] LY3314814
Serious: 0/8 (0%)
Deaths: 0/8
Other adverse events (3 terms — click to expand)

ReactionSystemLY3314814 + [13C415N3] LY3…
NasopharyngitisInfections and infestations
Oral herpesInfections and infestations
Dermatitis contactSkin and subcutaneous tissue disorders

Data from ClinicalTrials.gov NCT03222427 adverse events section.

Sponsor's own description

The purpose of this study is to measure how much LY3314814 gets into the bloodstream when it is given as a single dose by mouth and as an intravenous (IV) infusion over two hours. The study will last at least two weeks for each participant, not including screening.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Healthy

Currently open trials in the same condition.

Other AstraZeneca trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03222427.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing