Trial record 1 of 15 for:    LY2951742
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A Study of LY2951742 in Healthy Participants

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02576951
First received: October 14, 2015
Last updated: June 15, 2016
Last verified: June 2016
  Purpose

The purposes of this study are:

  • To evaluate tolerability of the LY2951742 solution injectable formulation (Part A)
  • To measure how much of the LY2951742 lyophilized (freeze dried) injectable formulation is absorbed into the blood stream and how long it takes the body to get rid of it compared to the LY2951742 solution injectable formulation after a single injection under the skin (subcutaneous [SC]) (Part B).

Information about any side effects that may occur will also be collected. Each part of the study will last about six months. Participants may only enroll in one part.


Condition Intervention Phase
Healthy
Drug: LY2951742
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Tolerability, Pharmacokinetics and Pharmacodynamics of LY2951742 in Healthy Subjects Following a Subcutaneous Administration of a Lyophilized Formulation or a Solution Formulation

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • The Number of Participants with an Injection Site Adverse Event [ Time Frame: Part A: Predose through 48 hours after study drug administration ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Relative Bioavailability of Lyophilized to Solution Formulations on the Basis of Area Under the Concentration Versus Time Curve (AUC) of LY2951742 [ Time Frame: Part B: Predose through 5 months after study drug administration ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Relative Bioavailability of Lyophilized to Solution Formulations on the Basis of Maximum Concentration (Cmax) of LY2951742 [ Time Frame: Part B: Predose through 5 months after study drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacodynamics (PD) of Plasma Calcitonin Gene Related Peptide (CGRP) [ Time Frame: Predose through 5 months after study drug administration ] [ Designated as safety issue: No ]
  • Area Under the Concentration Versus Time Curve (AUC) of Plasma Calcitonin Gene Related Peptide (CGRP) [ Time Frame: Predose through 5 months after study drug administration ] [ Designated as safety issue: No ]
  • Maximum Concentration (Cmax) of Plasma CGRP [ Time Frame: Predose through 5 months after study drug administration ] [ Designated as safety issue: No ]

Enrollment: 178
Study Start Date: October 2015
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2951742 Solution Formulation-Part A
LY2951742 solution formulation in a prefilled syringe given SC once.
Drug: LY2951742
Administered SC
Placebo Comparator: Placebo-Part A
Placebo in a prefilled syringe given SC once.
Drug: Placebo
Administered SC
Experimental: LY2951742 Lyophilized Formulation-Part B
LY2951742 lyophilized (freeze dried) formulation given SC once.
Drug: LY2951742
Administered SC
Experimental: LY2951742 Solution Formulation-Part B
LY2951742 solution formulation in a prefilled syringe given SC once.
Drug: LY2951742
Administered SC

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female healthy participants
  • Have a body mass index of 19.0 to 35.0 kilograms per meter square (kg/m²), inclusive

Exclusion Criteria:

- Currently smoke in excess of 5 cigarettes/day

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02576951

Locations
United States, Texas
Covance
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02576951     History of Changes
Other Study ID Numbers: 16084  I5Q-MC-CGAO 
Study First Received: October 14, 2015
Last Updated: June 15, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on August 23, 2016