drugset / Trial / NCT01705938
Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of SP-333 Tablets in Healthy Adult Subjects
RandomizedSingle-groupSingle-blindOther
Summary
This is a randomized, phase 1, single-blind, placebo-controlled, randomized, sequential, escalating, single-dose, study designed to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) properties of orally administered SP-333 tablets.
Timeline
- Start
- 2012-10
- Primary completion
- 2012-12
- Completion
- 2012-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dolcanatide | Protein / enzyme biologic | 0.1 mg | Oral |
| Comparator | Dolcanatide | Protein / enzyme biologic | 0.3 mg | Oral |
| Comparator | Dolcanatide | Protein / enzyme biologic | 1 mg | Oral |
| Comparator | Dolcanatide | Protein / enzyme biologic | 3 mg | Oral |
| Comparator | Dolcanatide | Protein / enzyme biologic | 10 mg | Oral |
| Comparator | Dolcanatide | Protein / enzyme biologic | 30 mg | Oral |
| Comparator | Dolcanatide | Protein / enzyme biologic | 60 mg | Oral |