A Study of Galcanezumab (LY2951742) in Healthy Chinese Participants

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04085289
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 6
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

The purpose of this study is to assess how fast galcanezumab gets into the blood stream and how long it takes the body to remove it. Information about side effects will be collected. The study is open to healthy Chinese participants. It will last up to about 24 weeks.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Galcanezumab; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: A Randomized, Placebo-Controlled, Single-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Galcanezumab in Healthy Chinese Subjects
• Actual Study Start Date: Nov 20, 2019
• Actual Primary Completion Date: May 21, 2020
• Actual Study Completion Date: May 21, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Galcanezumab Participants received single subcutaneous (SC) doses of 120 milligram (mg) or 240 mg Galcanezumab.	Drug: Galcanezumab; Administered SC; Other Names: LY2951742
Placebo Comparator: Placebo Participants received a single SC dose of Placebo.	Drug: Placebo; Administered SC

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab [8, 24, 48, 96, 120, 168, 216, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360 hours post-dose]

   Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab.

2. Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Galcanezumab [8, 24, 48, 96, 120, 168, 216, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360 hours post-dose]

   Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Galcanezumab.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Participants who are native Chinese (all 4 biological grandparents and both biological parents to be of Chinese origin)

• Participants who are overtly healthy males or females, as determined by medical history and physical examination

Exclusion Criteria:

• Participants who are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study

• Participants who have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed

• Participants who have received treatment with any CGRP (calcitonin gene related peptide) antibody (including galcanezumab), or antibody against CGRP receptor (including erenumab), or have received biologic agents (such as monoclonal antibodies) within 4 months or 5 half-lives (whichever is longer) prior to dosing

• Participants who have a history of multiple or severe allergies or has had an anaphylactic reaction to prescription or non-prescription drugs or food

• women who are lactating

• Participants who show evidence of positive human immunodeficiency virus antibodies, or positive hepatitis C antibody, or positive hepatitis B surface antigen, or active tuberculosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HuaShan Hospital Affiliated To Fudan University	Shanghai	Shanghai	China	20040

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

Study Documents (Full-Text)

• Study Protocol - Apr 9, 2019
• Statistical Analysis Plan - Oct 14, 2019

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT04085289
• Other Study ID Numbers: 17057; I5Q-MC-CGAY
• First Posted: Sep 11, 2019
• Last Update Posted: Jun 15, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Study Results

Participant Flow

Arm/Group Title	Placebo	120 mg Galcanezumab SC	240 mg Galcanezumab SC
Arm/Group Description	Participants received a single Subcutaneous (SC) dose of Placebo.	Participants received a single SC dose of 120 milligram (mg) Galcanezumab.	Participants received a single SC dose of 240 mg Galcanezumab.
Period Title: Overall Study
STARTED	6	12	12
Received at Least One Dose of Study Drug	6	12	12
COMPLETED	6	12	11
NOT COMPLETED	0	0	1

Baseline Characteristics

Arm/Group Title	Placebo	120 mg Galcanezumab SC	240 mg Galcanezumab SC	Total
Arm/Group Description	Participants received a single Subcutaneous (SC) dose of Placebo.	Participants received a single SC dose of 120 milligram (mg) Galcanezumab.	Participants received a single SC dose of 240 mg Galcanezumab.	Total of all reporting groups
Overall Participants	6	12	12	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26.70 (4.18)	26.80 (6.03)	28.80 (4.09)	27.60 (4.91)
Sex: Female, Male (Count of Participants)
Female	2 33.3%	4 33.3%	1 8.3%	7 23.3%
Male	4 66.7%	8 66.7%	11 91.7%	23 76.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	6 100%	12 100%	12 100%	30 100%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	6 100%	12 100%	12 100%	30 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
China	6 100%	12 100%	12 100%	30 100%

Outcome Measures

1. Primary Outcome

Title	Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab
Description	Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab.
Time Frame	8, 24, 48, 96, 120, 168, 216, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360 hours post-dose

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of Galcanezumab.

Arm/Group Title	120 mg Galcanezumab SC	240 mg Galcanezumab SC
Arm/Group Description	Participants received a single SC dose of 120 milligram (mg) Galcanezumab.	Participants received a single SC dose of 240 mg Galcanezumab.
Measure Participants	12	12
Geometric Mean (Geometric Coefficient of Variation) [micrograms per milliliter (μg/mL)]	12.6 (23)	27.2 (23)

2. Primary Outcome

Title	Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Galcanezumab
Description	Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Galcanezumab.
Time Frame	8, 24, 48, 96, 120, 168, 216, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360 hours post-dose

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of Galcanezumab.

Arm/Group Title	120 mg Galcanezumab SC	240 mg Galcanezumab SC
Arm/Group Description	Participants received a single SC dose of 120 milligram (mg) Galcanezumab.	Participants received a single SC dose of 240 mg Galcanezumab.
Measure Participants	12	12
Geometric Mean (Geometric Coefficient of Variation) [micrograms*day per milliliter(μg*day/mL)]	558 (36)	1190 (27)

Adverse Events

Time Frame	Baseline through Study Completion (Up To 20 weeks)
Adverse Event Reporting Description	All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Arm/Group Title	Placebo		120 mg Galcanezumab SC		240 mg Galcanezumab SC
Arm/Group Description	Participants received a single Subcutaneous (SC) dose of Placebo.		Participants received a single SC dose of 120 milligram (mg) Galcanezumab.		Participants received a single SC dose of 240 mg Galcanezumab.
All Cause Mortality
	Placebo		120 mg Galcanezumab SC		240 mg Galcanezumab SC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/12 (0%)		0/12 (0%)
Serious Adverse Events
	Placebo		120 mg Galcanezumab SC		240 mg Galcanezumab SC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		2/12 (16.7%)		1/12 (8.3%)
Injury, poisoning and procedural complications
Foot fracture	0/6 (0%)	0	0/12 (0%)	0	1/12 (8.3%)	1
Musculoskeletal and connective tissue disorders
Rhabdomyolysis	0/6 (0%)	0	1/12 (8.3%)	1	0/12 (0%)	0
Renal and urinary disorders
Ureterolithiasis	0/6 (0%)	0	1/12 (8.3%)	1	0/12 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo		120 mg Galcanezumab SC		240 mg Galcanezumab SC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/6 (83.3%)		12/12 (100%)		12/12 (100%)
Eye disorders
Dry eye	0/6 (0%)	0	1/12 (8.3%)	1	0/12 (0%)	0
Eye pain	0/6 (0%)	0	1/12 (8.3%)	1	0/12 (0%)	0
Gastrointestinal disorders
Abdominal pain	0/6 (0%)	0	1/12 (8.3%)	1	0/12 (0%)	0
Abdominal pain upper	1/6 (16.7%)	1	0/12 (0%)	0	0/12 (0%)	0
Aphthous ulcer	0/6 (0%)	0	1/12 (8.3%)	1	1/12 (8.3%)	3
Constipation	0/6 (0%)	0	1/12 (8.3%)	1	0/12 (0%)	0
Dry mouth	1/6 (16.7%)	1	1/12 (8.3%)	1	0/12 (0%)	0
General disorders
Asthenia	0/6 (0%)	0	0/12 (0%)	0	2/12 (16.7%)	2
Injection site haemorrhage	0/6 (0%)	0	0/12 (0%)	0	1/12 (8.3%)	1
Injection site reaction	1/6 (16.7%)	1	1/12 (8.3%)	1	1/12 (8.3%)	2
Swelling face	0/6 (0%)	0	0/12 (0%)	0	1/12 (8.3%)	1
Infections and infestations
Hordeolum	0/6 (0%)	0	0/12 (0%)	0	1/12 (8.3%)	1
Upper respiratory tract infection	0/6 (0%)	0	4/12 (33.3%)	6	2/12 (16.7%)	2
Investigations
Alanine aminotransferase increased	0/6 (0%)	0	3/12 (25%)	3	5/12 (41.7%)	5
Aspartate aminotransferase increased	0/6 (0%)	0	1/12 (8.3%)	1	2/12 (16.7%)	2
Bacterial test	0/6 (0%)	0	1/12 (8.3%)	1	0/12 (0%)	0
Blood pressure decreased	0/6 (0%)	0	1/12 (8.3%)	1	0/12 (0%)	0
Blood pressure increased	0/6 (0%)	0	0/12 (0%)	0	3/12 (25%)	8
Haemoglobin decreased	0/6 (0%)	0	1/12 (8.3%)	2	0/12 (0%)	0
Heart rate increased	1/6 (16.7%)	1	2/12 (16.7%)	2	1/12 (8.3%)	1
Lymphocyte percentage decreased	1/6 (16.7%)	1	0/12 (0%)	0	0/12 (0%)	0
Monocyte percentage increased	0/6 (0%)	0	0/12 (0%)	0	1/12 (8.3%)	1
Neutrophil percentage increased	1/6 (16.7%)	1	0/12 (0%)	0	0/12 (0%)	0
Platelet count decreased	1/6 (16.7%)	1	0/12 (0%)	0	0/12 (0%)	0
Protein urine present	0/6 (0%)	0	0/12 (0%)	0	2/12 (16.7%)	2
Urinary casts present	1/6 (16.7%)	1	0/12 (0%)	0	2/12 (16.7%)	3
White blood cell count decreased	1/6 (16.7%)	1	0/12 (0%)	0	0/12 (0%)	0
White blood cells urine positive	1/6 (16.7%)	1	0/12 (0%)	0	0/12 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	0/6 (0%)	0	0/12 (0%)	0	1/12 (8.3%)	1
Myalgia	0/6 (0%)	0	1/12 (8.3%)	1	0/12 (0%)	0
Pain in extremity	0/6 (0%)	0	0/12 (0%)	0	1/12 (8.3%)	1
Nervous system disorders
Headache	0/6 (0%)	0	2/12 (16.7%)	2	0/12 (0%)	0
Hypoaesthesia	0/6 (0%)	0	0/12 (0%)	0	1/12 (8.3%)	1
Pregnancy, puerperium and perinatal conditions
Pregnancy	0/2 (0%)	0	1/4 (25%)	1	0/1 (0%)	0
Psychiatric disorders
Insomnia	0/6 (0%)	0	1/12 (8.3%)	1	0/12 (0%)	0
Renal and urinary disorders
Ureterolithiasis	0/6 (0%)	0	0/12 (0%)	0	1/12 (8.3%)	1
Respiratory, thoracic and mediastinal disorders
Cough	0/6 (0%)	0	0/12 (0%)	0	1/12 (8.3%)	1
Epistaxis	2/6 (33.3%)	2	1/12 (8.3%)	1	0/12 (0%)	0
Nasal obstruction	0/6 (0%)	0	2/12 (16.7%)	2	2/12 (16.7%)	2
Oropharyngeal discomfort	0/6 (0%)	0	1/12 (8.3%)	1	0/12 (0%)	0
Oropharyngeal pain	1/6 (16.7%)	1	3/12 (25%)	3	0/12 (0%)	0
Skin and subcutaneous tissue disorders
Rash	0/6 (0%)	0	1/12 (8.3%)	1	0/12 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.