HealthyPhase 1NCT02576951

A Study of Galcanezumab in Healthy Participants

A Phase 1 study testing Galcanezumab in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

Completed

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

Trial summary

The purposes of this study are: To evaluate tolerability of the Galcanezumab solution injectable formulation (Part A) To measure how much of the Galcanezumab 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 Galcanezumab… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Galcanezumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 178 participants
Where: 1 siteUnited States
Study dates: 19 Oct 2015to 8 Jan 2018
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Currently smoke in excess of 5 cigarettes/day

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance
Dallas, Texas, 75247

Other trials in United States

About this study

Official title: Tolerability, Pharmacokinetics and Pharmacodynamics of LY2951742 in Healthy Subjects Following a Subcutaneous Administration of a Lyophilized Formulation or a Solution Formulation

The purposes of this study are:

To evaluate tolerability of the Galcanezumab solution injectable formulation (Part A)
To measure how much of the Galcanezumab 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 Galcanezumab 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.

Conditions: Healthy
Being tested: Galcanezumab, Placebo

What participants receive

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

GalcanezumabDrug
Also called LY2951742
Administered SC
PlaceboDrug
Administered SC

Study groups in NCT02576951
Study group	Role	What they receive
Galcanezumab Solution Formulation-Part A	Experimental	Galcanezumab solution formulation in a prefilled syringe given SC once. Receives: Drug: Galcanezumab
Placebo-Part A	Placebo comparator	Placebo in a prefilled syringe given SC once. Receives: Drug: Placebo
Galcanezumab Lyophilized Formulation-Part B	Experimental	Galcanezumab lyophilized (freeze dried) formulation given SC once. Receives: Drug: Galcanezumab
Galcanezumab Solution Formulation-Part B	Experimental	Galcanezumab solution formulation in a prefilled syringe given SC once. Receives: Drug: Galcanezumab

What is being measured

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

Part A: Number of Participants With an Injection Site Adverse Event
If an injection site reaction is present, it will be fully characterized (including erythema, induration, pain, itching). A summary of other nonserious adverse event (AE), and all serious adverse events (SAE), regardless of causality, is located in the reported adverse events section.
Measured: Part A: Predose through 48 hours post dose
Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity of Galcanezumab
Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) from Time Zero to Infinity of Galcanezumab.
Measured: Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose
Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab
Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab.
Measured: Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose

Secondary outcomes (6)

Part A: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP)
Part A: Pharmacodynamics (PD): Time to maximum concentration (tmax) of Plasma Calcitonin Gene Related Peptide (CGRP).
Measured: Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose
Part A: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC [0 to Tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP)
Part A: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC [0 to Tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP).
Measured: Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose
Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP
Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP.
Measured: Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose
Part B: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP)
Part B: Pharmacodynamics (PD): Time to maximum concentration (tmax) of Plasma Calcitonin Gene Related Peptide (CGRP).
Measured: Part B: Predose, 8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose
Part B: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP)
Part B: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve from time zero to tlast (AUC[0-tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP).
Measured: Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose
Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP
Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP.
Measured: Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose

Timeline

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

19 Oct 20158 Jan 2018

First posted15 Oct 2015 (estimated)
Study start19 Oct 2015
Primary completion3 Sep 2016
Study completion8 Jan 2018

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 178 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02576951
Sponsor's protocol ID: 16084
Other IDs: I5Q-MC-CGAO
Status last verified: Feb 2018
First submitted: 14 Oct 2015
Last updated: 26 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kielbasa W, Quinlan T. Population Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, Following Subcutaneous Dosing to Healthy Individuals and Patients With Migraine. J Clin Pharmacol. 2020 Feb;60(2):229-239. doi: 10.1002/jcph.1511. Epub 2019 Sep 4.
PubMed 31482569

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

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Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tolerability, Pharmacokinetics and Pharmacodynamics of LY2951742 in Healthy Subjects Following a Subcutaneous Administration of a Lyophilized Formulation or a Solution Formulation
ClinicalTrials.gov ID: NCT02576951
Acronym / sponsor ID: 16084
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 178 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 19 Oct 2015 (actual)
Primary completion: 3 Sep 2016 (actual)
Study completion: 8 Jan 2018 (actual)
First posted: 15 Oct 2015 (estimated)
Results: Posted 26 Feb 2019

Clinical summary

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

The purposes of this study are:

To evaluate tolerability of the Galcanezumab solution injectable formulation (Part A)
To measure how much of the Galcanezumab 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 Galcanezumab 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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Galcanezumab Solution Formulation-Part A	Experimental	Drug: GalcanezumabGalcanezumab solution formulation in a prefilled syringe given SC once.
Placebo-Part A	Placebo comparator	Drug: PlaceboPlacebo in a prefilled syringe given SC once.
Galcanezumab Lyophilized Formulation-Part B	Experimental	Drug: GalcanezumabGalcanezumab lyophilized (freeze dried) formulation given SC once.
Galcanezumab Solution Formulation-Part B	Experimental	Drug: GalcanezumabGalcanezumab solution formulation in a prefilled syringe given SC once.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

Currently smoke in excess of 5 cigarettes/day

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
GalcanezumabAlso: LY2951742Administered SC	Drug	Galcanezumab Lyophilized Formulation-Part B, Galcanezumab Solution Formulation-Part A, Galcanezumab Solution Formulation-Part B
PlaceboAdministered SC	Drug	Placebo-Part A

Primary outcome

Part A: Number of Participants With an Injection Site Adverse Event
Time frame: Part A: Predose through 48 hours post dose
If an injection site reaction is present, it will be fully characterized (including erythema, induration, pain, itching). A summary of other nonserious adverse event (AE), and all serious adverse events (SAE), regardless of causality, is located in the reported adverse events section.
Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity of Galcanezumab
Time frame: Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose
Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) from Time Zero to Infinity of Galcanezumab.
Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab
Time frame: Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose
Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab.

6 secondary outcomes

Part A: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP)
Time frame: Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose
Part A: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC [0 to Tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP)
Time frame: Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose
Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP
Time frame: Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose
Part B: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP)
Time frame: Part B: Predose, 8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose
Part B: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP)
Time frame: Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose
Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP
Time frame: Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose

Results and safety

Results posted to the registry on 26 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
240 mg Galcanezumab Solution - Part A	15	14
Placebo - Part A	3	3
300 mg Galcanezumab Lyophilized - Part B	80	78
300 mg Galcanezumab Solution - Part B	80	75

Primary outcome: Part A: Number of Participants With an Injection Site Adverse Event

Time frame: Part A: Predose through 48 hours post dose. Count of participants. Unit: Participants

Measure	240 mg Galcanezumab - Part A n = 15	Placebo - Part A n = 3
Value	3	0

Population analysed: All randomized participants who received at least one dose of study drug in Part A and had at least one post dose safety assessment.

Primary outcome: Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity of Galcanezumab

Time frame: Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose. Geometric mean (Geometric Coefficient of Variation). Unit: day*microgram per milliliter(day*μg/mL)

Measure	300mg Galcanezumab Solution - Part B n = 78	300 mg Galcanezumab Lyophilized - Part B n = 79
Value	1490 (31)	1670 (32)

Population analysed: All randomized participants who received at least one dose of study drug in Part B and had evaluable AUC zero to infinity PK data.

Primary outcome: Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab

Measure	300 mg Galcanezumab Solution - Part B n = 78	300 mg Galcanezumab Lyophilized - Part B n = 79
Value	38 (30)	42.4 (28)

Population analysed: All randomized participants who received at least one dose of study drug in part B and had evaluable Cmax PK data.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 20 Weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Galcanezumab 240 mg - Part A	0 of 15 (0%)	7 of 15 (46.7%)	0 of 15
Placebo - Part A	1 of 3 (33.3%)	1 of 3 (33.3%)	0 of 3
Galcanezumab 300 mg Lyophilized - Part B	1 of 80 (1.3%)	25 of 80 (31.3%)	0 of 80
Galcanezumab 300 mg Solution - Part B	0 of 80 (0%)	20 of 80 (25%)	0 of 80

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31482569Kielbasa W, Quinlan T. Population Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, Following Subcutaneous Dosing to Healthy Individuals and Patients With Migraine. J Clin Pharmacol. 2020 Feb;60(2):229-239. doi: 10.1002/jcph.1511. Epub 2019 Sep 4.

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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 Galcanezumab in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

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 2 inclusion and 1 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 26 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 United States. 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 26 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?

Part A: Number of Participants With an Injection Site Adverse Event (time frame: Part A: Predose through 48 hours post dose). The study lists 3 primary outcomes in all. 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 NCT02576951, which also lists 1 linked publication.

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 26 Feb 2019.