Trial Outcomes & Findings for A Study of Galcanezumab in Healthy Participants (NCT NCT02576951)

Last Updated: 2019-02-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

178 participants

Primary outcome timeframe

Part A: Predose through 48 hours post dose

Results posted on

2019-02-26

Participant Flow

Participant milestones

Participant milestones
Measure	240 mg Galcanezumab Solution - Part A Participants received 240 milligram (mg) Galcanezumab as a solution formulation by subcutaneous injection.	Placebo - Part A Participants received placebo by subcutaneous injection.	300 mg Galcanezumab Lyophilized - Part B Participants received 300 mg Galcanezumab as a lyophilized formulation by subcutaneous injection.	300 mg Galcanezumab Solution - Part B Participants received 300 mg Galcanezumab as a solution formulation by subcutaneous injection
Overall Study STARTED	15	3	80	80
Overall Study Received at Least One Dose of Study Drug	15	3	80	80
Overall Study COMPLETED	14	3	78	75
Overall Study NOT COMPLETED	1	0	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	240 mg Galcanezumab Solution - Part A Participants received 240 milligram (mg) Galcanezumab as a solution formulation by subcutaneous injection.	300 mg Galcanezumab Lyophilized - Part B Participants received 300 mg Galcanezumab as a lyophilized formulation by subcutaneous injection.	300 mg Galcanezumab Solution - Part B Participants received 300 mg Galcanezumab as a solution formulation by subcutaneous injection
Overall Study Lost to Follow-up	0	2	2
Overall Study Withdrawal by Subject	1	0	2
Overall Study Protocol Violation	0	0	1

Baseline Characteristics

A Study of Galcanezumab in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	240 mg Galcanezumab Solution - Part A n=15 Participants Participants received 240 mg Galcanezumab as a solution formulation by subcutaneous injection.	Placebo - Part A n=3 Participants Participants received placebo by subcutaneous injection.	300 mg Galcanezumab Lyophilized - Part B n=80 Participants Participants received 300 mg Galcanezumab as a lyophilized formulation by subcutaneous injection.	300 mg Galcanezumab Solution - Part B n=80 Participants Participants received 300 mg Galcanezumab as a solution formulation by subcutaneous injection.	Total n=178 Participants Total of all reporting groups
Age, Continuous	49.5 years STANDARD_DEVIATION 12.1 • n=5 Participants	45.7 years STANDARD_DEVIATION 14.5 • n=7 Participants	38.5 years STANDARD_DEVIATION 11.4 • n=5 Participants	40.6 years STANDARD_DEVIATION 12.8 • n=4 Participants	40.5 years STANDARD_DEVIATION 12.44 • n=21 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	3 Participants n=7 Participants	36 Participants n=5 Participants	38 Participants n=4 Participants	86 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	0 Participants n=7 Participants	44 Participants n=5 Participants	42 Participants n=4 Participants	92 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	1 Participants n=7 Participants	43 Participants n=5 Participants	36 Participants n=4 Participants	85 Participants n=21 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	2 Participants n=7 Participants	30 Participants n=5 Participants	34 Participants n=4 Participants	74 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants	13 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	15 participants n=5 Participants	3 participants n=7 Participants	80 participants n=5 Participants	80 participants n=4 Participants	178 participants n=21 Participants
Basal Metabolic Index (BMI)	26.27 Kilogram per square meter STANDARD_DEVIATION 3.86 • n=5 Participants	30.67 Kilogram per square meter STANDARD_DEVIATION 4.32 • n=7 Participants	27.57 Kilogram per square meter STANDARD_DEVIATION 4.14 • n=5 Participants	27.55 Kilogram per square meter STANDARD_DEVIATION 3.97 • n=4 Participants	27.56 Kilogram per square meter STANDARD_DEVIATION 4.04 • n=21 Participants

PRIMARY outcome

Timeframe: Part A: Predose through 48 hours post dose

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

Outcome measures

Outcome measures
Measure	240 mg Galcanezumab - Part A n=15 Participants Participants received 240 mg Galcanezumab as a solution formulation by subcutaneous injection.	Placebo - Part A n=3 Participants Participants received placebo by subcutaneous injection.
Part A: Number of Participants With an Injection Site Adverse Event	3 Participants	0 Participants

PRIMARY outcome

Timeframe: Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose

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

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

Outcome measures

Outcome measures
Measure	240 mg Galcanezumab - Part A n=78 Participants Participants received 240 mg Galcanezumab as a solution formulation by subcutaneous injection.	Placebo - Part A n=79 Participants Participants received placebo by subcutaneous injection.
Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity of Galcanezumab	1490 daymicrogram per milliliter(dayμg/mL) Geometric Coefficient of Variation 31	1670 daymicrogram per milliliter(dayμg/mL) Geometric Coefficient of Variation 32

PRIMARY outcome

Timeframe: Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose

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

Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab.

Outcome measures

Outcome measures
Measure	240 mg Galcanezumab - Part A n=78 Participants Participants received 240 mg Galcanezumab as a solution formulation by subcutaneous injection.	Placebo - Part A n=79 Participants Participants received placebo by subcutaneous injection.
Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab	38 Microgram per milliliter (μg/mL) Geometric Coefficient of Variation 30	42.4 Microgram per milliliter (μg/mL) Geometric Coefficient of Variation 28

SECONDARY outcome

Timeframe: Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose

Population: All randomized participants who received at least one dose of study drug and had evaluable plasma Tmax CGRP data in Part A.

Part A: Pharmacodynamics (PD): Time to maximum concentration (tmax) of Plasma Calcitonin Gene Related Peptide (CGRP).

Outcome measures

Outcome measures
Measure	240 mg Galcanezumab - Part A n=14 Participants Participants received 240 mg Galcanezumab as a solution formulation by subcutaneous injection.	Placebo - Part A Participants received placebo by subcutaneous injection.
Part A: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP)	56.01 Days Interval 28.04 to 112.01	—

SECONDARY outcome

Timeframe: Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose

Population: All randomized participants who received at least one dose of study drug and had evaluable plasma AUC CGRP data in Part A.

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).

Outcome measures

Outcome measures
Measure	240 mg Galcanezumab - Part A n=14 Participants Participants received 240 mg Galcanezumab as a solution formulation by subcutaneous injection.	Placebo - Part A Participants received placebo by subcutaneous injection.
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)	231 day*ng/mL Geometric Coefficient of Variation 48	—

SECONDARY outcome

Timeframe: Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose

Population: All randomized participants who received at least one dose of study drug and had evaluable plasma Cmax CGRP data in Part A.

Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP.

Outcome measures

Outcome measures
Measure	240 mg Galcanezumab - Part A n=14 Participants Participants received 240 mg Galcanezumab as a solution formulation by subcutaneous injection.	Placebo - Part A Participants received placebo by subcutaneous injection.
Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP	2.64 ng/mL Geometric Coefficient of Variation 34	—

SECONDARY outcome

Timeframe: Part B: Predose, 8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose

Population: All randomized participants who received at least one dose of study drug and had evaluable plasma Tmax CGRP data in Part B.

Part B: Pharmacodynamics (PD): Time to maximum concentration (tmax) of Plasma Calcitonin Gene Related Peptide (CGRP).

Outcome measures

Outcome measures
Measure	240 mg Galcanezumab - Part A n=78 Participants Participants received 240 mg Galcanezumab as a solution formulation by subcutaneous injection.	Placebo - Part A n=79 Participants Participants received placebo by subcutaneous injection.
Part B: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP)	41.93 Days Interval 20.93 to 84.03	41.95 Days Interval 13.92 to 83.95

SECONDARY outcome

Timeframe: Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose

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

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).

Outcome measures

Outcome measures
Measure	240 mg Galcanezumab - Part A n=75 Participants Participants received 240 mg Galcanezumab as a solution formulation by subcutaneous injection.	Placebo - Part A n=78 Participants Participants received placebo by subcutaneous injection.
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)	169 day*ng/mL Geometric Coefficient of Variation 50	192 day*ng/mL Geometric Coefficient of Variation 50

SECONDARY outcome

Timeframe: Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose

Population: All randomized participants who received at least one dose of study drug and had evaluable plasma Cmax CGRP data in Part B.

Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP.

Outcome measures

Outcome measures
Measure	240 mg Galcanezumab - Part A n=78 Participants Participants received 240 mg Galcanezumab as a solution formulation by subcutaneous injection.	Placebo - Part A n=79 Participants Participants received placebo by subcutaneous injection.
Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP	2.19 ng/mL Geometric Coefficient of Variation 36	2.38 ng/mL Geometric Coefficient of Variation 34

Adverse Events

Galcanezumab 240 mg - Part A

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo - Part A

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Galcanezumab 300 mg Lyophilized - Part B

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Galcanezumab 300 mg Solution - Part B

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Galcanezumab 240 mg - Part A n=15 participants at risk Participants received 240 mg Galcanezumab as a solution formulation by subcutaneous injection.	Placebo - Part A n=3 participants at risk Participants received placebo by subcutaneous injection.	Galcanezumab 300 mg Lyophilized - Part B n=80 participants at risk Participants received 300 mg Galcanezumab as a lyophilized formulation by subcutaneous injection.	Galcanezumab 300 mg Solution - Part B n=80 participants at risk Participants received 300 mg Galcanezumab as a solution formulation by subcutaneous injection.
Cardiac disorders Atrial fibrillation	0.00% 0/15 • Up to 20 Weeks All randomized participants.	0.00% 0/3 • Up to 20 Weeks All randomized participants.	1.2% 1/80 • Number of events 1 • Up to 20 Weeks All randomized participants.	0.00% 0/80 • Up to 20 Weeks All randomized participants.
Infections and infestations Cellulitis	0.00% 0/15 • Up to 20 Weeks All randomized participants.	33.3% 1/3 • Number of events 1 • Up to 20 Weeks All randomized participants.	0.00% 0/80 • Up to 20 Weeks All randomized participants.	0.00% 0/80 • Up to 20 Weeks All randomized participants.

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER