Phase 1
Completed N=178
A Study of Galcanezumab in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT02576951 ↗
Enrolled (actual)
178
Serious AEs
1.1%
Results posted
Feb 2019
Primary outcomePrimary: Part A: Number of Participants With an Injection Site Adverse Event — 3; 0 Participants
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Number of Participants With an Injection Site Adverse Event |
3; 0 | — |
| PRIMARY Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity of Galcanezumab |
1490; 1670 | — |
| PRIMARY Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab |
38; 42.4 | — |
| SECONDARY Part A: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP) |
56.01 | — |
| SECONDARY 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 | — |
| SECONDARY Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP |
2.64 | — |
| SECONDARY Part B: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP) |
41.93; 41.95 | — |
| SECONDARY 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; 192 | — |
| SECONDARY Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP |
2.19; 2.38 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female healthy participants
- Have a body mass index of 19.0 to 35.0 kilograms per meter square (kg/m²), inclusive
Exclusion Criteria
- Currently smoke in excess of 5 cigarettes/day
Data sourced from ClinicalTrials.gov (NCT02576951). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.