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A Study of Galcanezumab (LY2951742) in Healthy Chinese Participants
Phase 1 trial testing Galcanezumab in Healthy in 30 participants. Completed in 21 May 2020.
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | basic science |
| Enrollment | 30 |
| Start date | 20 November 2019 |
| Primary completion | 21 May 2020 |
| Estimated completion | 21 May 2020 |
| Sites | 1 location across China |
Eli Lilly and Company — full company profile →
18 and older, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab.
| Group | Value | 95% CI |
|---|---|---|
| 120 mg Galcanezumab SC | 12.6 | ± 23 |
| 240 mg Galcanezumab SC | 27.2 | ± 23 |
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC\[0-∞\]) of Galcanezumab.
| Group | Value | 95% CI |
|---|---|---|
| 120 mg Galcanezumab SC | 558 | ± 36 |
| 240 mg Galcanezumab SC | 1190 | ± 27 |
Time frame: Baseline through Study Completion (Up To 20 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo | 120 mg Galcanezumab SC | 240 mg Galcanezumab SC |
|---|---|---|---|---|
| Foot fracture | Injury, poisoning and procedural complications | — | — | — |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | — | — | — |
| Ureterolithiasis | Renal and urinary disorders | — | — | — |
| Reaction | System | Placebo | 120 mg Galcanezumab SC | 240 mg Galcanezumab SC |
|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — |
| Blood pressure increased | Investigations | — | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Asthenia | General disorders | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — |
| Heart rate increased | Investigations | — | — | — |
| Protein urine present | Investigations | — | — | — |
| Urinary casts present | Investigations | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Dry eye | Eye disorders | — | — | — |
| Eye pain | Eye disorders | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — |
| Aphthous ulcer | Gastrointestinal disorders | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — |
| Dry mouth | Gastrointestinal disorders | — | — | — |
| Injection site haemorrhage | General disorders | — | — | — |
| Injection site reaction | General disorders | — | — | — |
| Swelling face | General disorders | — | — | — |
| Hordeolum | Infections and infestations | — | — | — |
| Bacterial test | Investigations | — | — | — |
| Blood pressure decreased | Investigations | — | — | — |
| Haemoglobin decreased | Investigations | — | — | — |
| Lymphocyte percentage decreased | Investigations | — | — | — |
| Monocyte percentage increased | Investigations | — | — | — |
| Neutrophil percentage increased | Investigations | — | — | — |
| Platelet count decreased | Investigations | — | — | — |
| White blood cell count decreased | Investigations | — | — | — |
| White blood cells urine positive | Investigations | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — |
| Hypoaesthesia | Nervous system disorders | — | — | — |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — |
| Ureterolithiasis | Renal and urinary disorders | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
Most-reported serious reactions: Foot fracture, Rhabdomyolysis, Ureterolithiasis.
Data from ClinicalTrials.gov NCT04085289 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing