Trials / Completed
CompletedNCT03229798
Sofusa System With Sumatriptan (KC5010) Phase 1 Dose Escalation Safety and PK Study (KCC-SMT-002)
An Open-Label Phase 1 Study to Establish the Pharmacokinetics and Safety of Sumatriptan Succinate Administered Via the Sofusa™ DoseConnect™ System at Escalating Doses Compared to Oral Imitrex® Single 100 mg Dose in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Sorrento Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
Study KCC-SMT-002, is a Phase 1, single-site, open-label, non-randomized, crossover, flexible dose design study to investigate the pharmacokinetic (PK) and safety comparing the Sofusa™ system with sumatriptan (KC5010) to Imitrex® oral tablets in 17 healthy volunteers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sumatriptan Succinate Oral Tablet | Sumatriptan succinate commercial Imitrex 100 mg tablet |
| COMBINATION_PRODUCT | Transdermal delivery of sumatriptan succinate | Sumatriptan succinate transdermal drug delivery system |
Timeline
- Start date
- 2018-01-17
- Primary completion
- 2018-03-28
- Completion
- 2018-03-28
- First posted
- 2017-07-26
- Last updated
- 2022-08-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03229798. Inclusion in this directory is not an endorsement.