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A Pilot Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Needle Safety Device (PFS+NSD) in Healthy Participants
Phase 1 trial testing Vedolizumab SC in Healthy Volunteers in 102 participants. Completed in 21 September 2018.
| Lead sponsor | Takeda |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 102 |
| Start date | 21 February 2018 |
| Primary completion | 14 August 2018 |
| Estimated completion | 21 September 2018 |
| Sites | 1 location across United States |
Takeda — full company profile →
Adults 18 to 65, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
| Group | Value | 95% CI |
|---|---|---|
| Group A: Vedolizumab SC PFS | 492.6 | ± 22.5 |
| Group B: Vedolizumab SC Investigational Device | 455.4 | ± 34.4 |
| Group | Value | 95% CI |
|---|---|---|
| Group A: Vedolizumab SC PFS | 504.4 | ± 22.0 |
| Group B: Vedolizumab SC Investigational Device | 478.4 | ± 30.7 |
| Group | Value | 95% CI |
|---|---|---|
| Group A: Vedolizumab SC PFS | 15.42 | ± 19.9 |
| Group B: Vedolizumab SC Investigational Device | 14.86 | ± 24.4 |
Time frame: Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Group A: Vedolizumab SC PFS | Group B: Vedolizumab SC In… |
|---|---|---|---|
| Injection site pain | General disorders | — | — |
| Injection site induration | General disorders | — | — |
| Injection site erythema | General disorders | — | — |
| Weight increased | Investigations | — | — |
| Headache | Nervous system disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Eyelid odema | Eye disorders | — | — |
| Iridocyclitis | Eye disorders | — | — |
| Vision blurred | Eye disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Aphthous ulcer | Gastrointestinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Flatulence | Gastrointestinal disorders | — | — |
| Noninfective gingivitis | Gastrointestinal disorders | — | — |
| Toothache | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Chest discomfort | General disorders | — | — |
| Influenza like illness | General disorders | — | — |
| Thirst | General disorders | — | — |
| Cellulitis | Infections and infestations | — | — |
| Oral herpes | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Viral infection | Infections and infestations | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Muscle strain | Injury, poisoning and procedural complications | — | — |
| Weight decreased | Investigations | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Presyncope | Nervous system disorders | — | — |
| Somnolence | Nervous system disorders | — | — |
| Haematuria | Renal and urinary disorders | — | — |
| Pollakiuria | Renal and urinary disorders | — | — |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — |
| Productive cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Dermatitis contact | Skin and subcutaneous tissue disorders | — | — |
Data from ClinicalTrials.gov NCT03948581 adverse events section.
The purpose of this study is to compare the PK of single dose of vedolizumab SC 108 milligram (mg) administered as PFS vs investigational device.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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