A Study of LY2951742 in Healthy Volunteers

NCT01337596 | Completed Phase 1 Results

• 2 other identifiers: 14248I5Q-MC-CGAA
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and tolerability of LY2951742 given as single or multiple subcutaneous injection in healthy male subjects

Conditions

Migraines

Keywords

pain; neuropathic pain; headaches

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinically Significant Effects

  Clinically significant effects were defined as serious and other non-serious adverse events (AEs). A summary of serious and all other non-serious AEs is located in the Reported Adverse Events module.

  Baseline up to 6 months (study completion)

Secondary Outcomes (4)

• Single Dose Pharmacokinetics of LY2951742 Maximal Concentration (Cmax)

  Day 1 up to Day 84 or early discontinuation

• Single Dose Pharmacokinetics of LY2951742 Area Under the Curve (AUC)

  Day 1 up to Day 84 or early discontinuation

• Multiple Dose Pharmacokinetics of LY2951742 Maximal Concentration (Cmax)

  Day 43 up to Day 57

• Multiple Dose Pharmacokinetics of LY2951742 Area Under the Curve (AUC)

  Day 43 up to Day 57

Study Arms (9)

Single dose 1 milligram (mg) LY2951742

EXPERIMENTAL

Administered single subcutaneous injection

Drug: LY2951742

Single dose 5 mg LY2951742

EXPERIMENTAL

Administered single subcutaneous injection

Drug: LY2951742

Single dose 25 mg LY2951742

EXPERIMENTAL

Administered single subcutaneous injection

Drug: LY2951742

Single dose 75 mg LY2951742

EXPERIMENTAL

Administered single subcutaneous injection

Drug: LY2951742

Single dose 200 mg LY2951742

EXPERIMENTAL

Administered single subcutaneous injection

Drug: LY2951742

Single dose 600 mg LY2951742

EXPERIMENTAL

Administered single subcutaneous injection

Drug: LY2951742

Single dose placebo

PLACEBO COMPARATOR

Administered single subcutaneous injection

Drug: Placebo

Multiple dose placebo

PLACEBO COMPARATOR

Administered subcutaneously every 2 weeks for 6 weeks (4 doses)

Drug: Placebo

150 mg LY2951742

EXPERIMENTAL

Administered subcutaneously every 2 weeks for 6 weeks (4 doses)

Drug: LY2951742

Interventions

LY2951742 DRUG

Administered subcutaneously

150 mg LY2951742; Single dose 1 milligram (mg) LY2951742; Single dose 200 mg LY2951742; Single dose 25 mg LY2951742; Single dose 5 mg LY2951742; Single dose 600 mg LY2951742; Single dose 75 mg LY2951742

Placebo DRUG

Administered subcutaneously

Multiple dose placebo; Single dose placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Are healthy Caucasian males, as determined by medical history and physical examination
• Agree to use a reliable method of birth control (e.g. condom AND additional contraception method to be used by respective partner) during the study and for 3 months following the last dose of the investigational product
• Have a body mass index (BMI) greater than 19 kilogram/square meter (kg/m\^2)
• Have clinical laboratory test results within normal reference range for the population or investigator site
• Have venous access sufficient to allow for blood sampling
• Are willing to follow study procedures including no drugs (exception of study drug) 72 hours prior to initiation of the laser doppler imaging (LDI) procedure, no chocolate, alcohol or caffeine containing products 12 hours prior to initiation of the laser doppler imaging (LDI) procedure, and complete a 4 hour fast prior to initiation of the laser doppler imaging (LDI) procedure
• Have suitable skin characteristics for the dermal capsaicin challenge and have demonstrated a 100 percent increase in dermal flow following capsaicin challenge as part of the screening procedures and measured by laser doppler imaging (LDI)

You may not qualify if:

• Are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product; or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
• Are persons who have previously received the investigational product in this study, have completed or withdrawn from this study investigating LY2951742
• Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study including QTc greater than 450 milliseconds (msec) (male), history of congenital long QT syndrome or other conduction abnormality
• Have abnormal vital signs as determined by the investigator
• Have a history or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders (including migraine) that would constitute a risk when taking the study medication; or of interfering with the interpretation of data study
• Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
• Show evidence of:
• Human immunodeficiency virus infection and/or positive human immunodeficiency virus (HIV) antibodies
• Hepatitis C and/or positive hepatitis C antibody
• Hepatitis B and/or positive hepatitis B surface antigen
• Intend to use over-the-counter or prescription medication that may interfere with study safety assessments or other measurements within 7 days prior to dosing and during the study (example: systemic glucocorticoids, immunomodulatory drugs, drugs with propensity for dermal reactions, and drugs with known liver toxicity).
• Have donated blood of more than 500 milliliter (mL) or has undergone major surgery
• The use of caffeine containing products and alcohol is not allowed from 12 hours prior to all study visits and during in clinic stays. All other times, alcohol consumption and caffeine intake are limited to no more than 2 alcoholic beverages or equivalent (beer \[284 mL/10 ounces\], wine \[125 mL/4 ounces\], or distilled spirits (25 milliliter \[mL/1 ounce\]) per day and caffeinated beverages will be limited to no more than 2 units per day amounts (1 unit=120 milligrams \[mg\] of caffeine). Strenuous activity is not allowed from 1 week prior to admission until the follow-up visit.
• Are smokers within the previous 6 months
• Have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer)prior to dosing or have received a vaccination within 1 month

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Leuven, Belgium

Location

MeSH Terms

Conditions

Migraine Disorders; Pain; Neuralgia; Headache

Interventions

galcanezumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly Company

1-800-545-5979

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 19, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: February 20, 2019
• Results First Posted: February 20, 2019

Record last verified: 2012-05

Locations

BE (1)