MigrainesPhase 1NCT01337596

A Study of LY2951742 in Healthy Volunteers

A Phase 1 study testing LY2951742 in people with Migraines, run by Eli Lilly and Company at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To evaluate the safety and tolerability of LY2951742 given as single or multiple subcutaneous injection in healthy male subjects Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Migraines
What is being tested?: LY2951742
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 63 participants
Where: 1 siteBelgium
Study dates: Apr 2011to Apr 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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)

Who cannot join

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 all 22Show fewer

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
Have a history of multiple or severe allergies or has had an anaphylactic reaction or intolerability to prescription or non-prescription drugs or food
Are immunocompromised
Have had cancer or within the past 5 years
Have a history of significant allergies, in particular to ethanol or sensitivity to the fruits of capsicum plants (example: chili peppers)
Have eczema, scleroderma, psoriasis, dermatitis, keloids, tumors, ulcers, burns, flaps, or grafts on their forearm or other abnormality of the skin which may interfere with the study assessments
Cannot avoid excess tanning (any exposure to sunlight or a tanning bed which would cause a sunburn reaction) throughout the study and cannot cover forearms for 24 hours prior to treatment period
Have excessive hair growth on the volar surface of the forearm or subjects currently using lotions, oils, depilatory preparations, or other topical treatments on a regular basis which cannot be discontinued for the duration of the study; subject has used any topical treatments within 7 days of the start of the study

Trial locations and contacts

1 site in 1 country.

Belgium1 site

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

Other trials in Belgium

About this study

Official title: A Safety, Tolerability, and Pharmacokinetic Study of Single, Escalating Subcutaneous Doses of LY2951742 in Healthy Volunteers

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

Conditions: Migraines
Being tested: LY2951742, Placebo
Keywords: pain, neuropathic pain, headaches
Medical subject headings: Migraine Disorders, Pain, Neuralgia, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY2951742Drug
Administered subcutaneously
PlaceboDrug
Administered subcutaneously

Study groups in NCT01337596
Study group	Role	What they receive
Single dose 1 milligram (mg) LY2951742	Experimental	Administered single subcutaneous injection Receives: Drug: LY2951742
Single dose 5 mg LY2951742	Experimental	Administered single subcutaneous injection Receives: Drug: LY2951742
Single dose 25 mg LY2951742	Experimental	Administered single subcutaneous injection Receives: Drug: LY2951742
Single dose 75 mg LY2951742	Experimental	Administered single subcutaneous injection Receives: Drug: LY2951742
Single dose 200 mg LY2951742	Experimental	Administered single subcutaneous injection Receives: Drug: LY2951742
Single dose 600 mg LY2951742	Experimental	Administered single subcutaneous injection Receives: Drug: LY2951742
Single dose placebo	Placebo comparator	Administered single subcutaneous injection Receives: Drug: Placebo
Multiple dose placebo	Placebo comparator	Administered subcutaneously every 2 weeks for 6 weeks (4 doses) Receives: Drug: Placebo
150 mg LY2951742	Experimental	Administered subcutaneously every 2 weeks for 6 weeks (4 doses) Receives: Drug: LY2951742

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline up to 6 months (study completion)

Secondary outcomes (4)

Single Dose Pharmacokinetics of LY2951742 Maximal Concentration (Cmax)
Measured: Day 1 up to Day 84 or early discontinuation
Single Dose Pharmacokinetics of LY2951742 Area Under the Curve (AUC)
Measured: Day 1 up to Day 84 or early discontinuation
Multiple Dose Pharmacokinetics of LY2951742 Maximal Concentration (Cmax)
Measured: Day 43 up to Day 57
Multiple Dose Pharmacokinetics of LY2951742 Area Under the Curve (AUC)
Measured: Day 43 up to Day 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Apr 2012

First posted19 Apr 2011 (estimated)
Study startApr 2011
Primary completionApr 2012
Study completionApr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MigrainesStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01337596
Sponsor's protocol ID: 14248
Other IDs: I5Q-MC-CGAA
Status last verified: May 2012
First submitted: 15 Apr 2011
Last updated: 20 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Enrolling by invitation
App-based Breathing Program for Migraine Relief
Migraine, Heart Rate Variability (HRV)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)

All Migraines trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Safety, Tolerability, and Pharmacokinetic Study of Single, Escalating Subcutaneous Doses of LY2951742 in Healthy Volunteers
ClinicalTrials.gov ID: NCT01337596
Acronym / sponsor ID: 14248
Conditions: Migraines
Keywords: pain, neuropathic pain, headaches
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Apr 2011
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 19 Apr 2011 (estimated)
Results: Posted 20 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 9

Arm	Type	Receives
Single dose 1 milligram (mg) LY2951742	Experimental	Drug: LY2951742Administered single subcutaneous injection
Single dose 5 mg LY2951742	Experimental	Drug: LY2951742Administered single subcutaneous injection
Single dose 25 mg LY2951742	Experimental	Drug: LY2951742Administered single subcutaneous injection
Single dose 75 mg LY2951742	Experimental	Drug: LY2951742Administered single subcutaneous injection
Single dose 200 mg LY2951742	Experimental	Drug: LY2951742Administered single subcutaneous injection
Single dose 600 mg LY2951742	Experimental	Drug: LY2951742Administered single subcutaneous injection
Single dose placebo	Placebo comparator	Drug: PlaceboAdministered single subcutaneous injection
Multiple dose placebo	Placebo comparator	Drug: PlaceboAdministered subcutaneously every 2 weeks for 6 weeks (4 doses)
150 mg LY2951742	Experimental	Drug: LY2951742Administered subcutaneously every 2 weeks for 6 weeks (4 doses)

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (22 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY2951742Administered subcutaneously	Drug	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
PlaceboAdministered subcutaneously	Drug	Multiple dose placebo, Single dose placebo

Primary outcome

Number of Participants With Clinically Significant Effects
Time frame: Baseline up to 6 months (study completion)
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.

4 secondary outcomes

Single Dose Pharmacokinetics of LY2951742 Maximal Concentration (Cmax)
Time frame: Day 1 up to Day 84 or early discontinuation
Single Dose Pharmacokinetics of LY2951742 Area Under the Curve (AUC)
Time frame: Day 1 up to Day 84 or early discontinuation
Multiple Dose Pharmacokinetics of LY2951742 Maximal Concentration (Cmax)
Time frame: Day 43 up to Day 57
Multiple Dose Pharmacokinetics of LY2951742 Area Under the Curve (AUC)
Time frame: Day 43 up to Day 57

Results and safety

Results posted to the registry on 20 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1 mg Single Dose LY2951742	7	7
5 mg Single Dose LY2951742	7	7
25 mg Single Dose LY2951742	7	7
75 mg Single Dose LY2951742	7	7
200 mg Single Dose LY2951742	7	5
600 mg Single Dose LY2951742	7	7
Placebo Single Dose	12	12
Placebo Multiple Dose	2	2
150 mg Multiple Dose LY2951742	7	7

Primary outcome: Number of Participants With Clinically Significant Effects

Time frame: Baseline up to 6 months (study completion). Number. Unit: participants

Measure	1 Milligram (mg) Single Dose LY2951742 n = 7	5 mg Single Dose LY2951742 n = 7	25 mg Single Dose LY2951742 n = 7	75 mg Single Dose LY2951742 n = 7	200 mg Single Dose LY2951742 n = 7	600 mg Single Dose LY2951742 n = 7	Placebo Single Dose n = 12	Placebo Multiple Dose n = 2	150 mg Multiple Dose LY2951742 n = 7
Serious Adverse Events	0	0	0	0	0	0	0	0	0
Other Non-Serious Adverse Events	6	5	7	4	7	5	9	2	7

Population analysed: Safety Population: All participants who received at least 1 dose of the study drug.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1 mg Single Dose LY2951742	0 of 7 (0%)	6 of 7 (85.7%)	Not reported
5 mg Single Dose LY2951742	0 of 7 (0%)	5 of 7 (71.4%)	Not reported
25 mg Single Dose LY2951742	0 of 7 (0%)	7 of 7 (100%)	Not reported
75 mg Single Dose LY2951742	0 of 7 (0%)	4 of 7 (57.1%)	Not reported
200 mg Single Dose LY2951742	0 of 7 (0%)	7 of 7 (100%)	Not reported
600 mg Single Dose LY2951742	0 of 7 (0%)	5 of 7 (71.4%)	Not reported
Placebo Single Dose	0 of 12 (0%)	9 of 12 (75%)	Not reported
Placebo Multiple Dose	0 of 2 (0%)	2 of 2 (100%)	Not reported
150 mg Multiple Dose LY2951742	0 of 7 (0%)	7 of 7 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Migraines

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Enrolling by invitation
App-based Breathing Program for Migraine Relief
Migraine, Heart Rate Variability (HRV)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2951742 in people with Migraines, run by Eli Lilly and Company at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Clinically Significant Effects (time frame: Baseline up to 6 months (study completion)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01337596.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.