drugset / Trial / NCT04309526
Safety, Tolerability and Pharmacokinetics of NCO-48 Fumarate in Healthy Subjects
Phase 1
Completed
48 enrolled
Nucorion Pharmaceuticals, Inc.
Ligand Pharmaceuticals · collabMedpace, Inc. · collab
RandomizedSequentialQuadruple-blindTreatment
Summary
The primary objective is to evaluate the safety and tolerability of single oral doses of NCO-48 Fumarate in healthy subjects. The secondary objectives are to evaluate the pharmacokinetic (PK) profile of NCO-48 Fumarate and its active metabolite, tenofovir (TFV), in healthy subjects following single oral doses and to evaluate the effect of food on the PK of a 30 mg dose of NCO-48 Fumarate in healthy subjects.
Timeline
- Start
- 2020-03-18
- Primary completion
- 2020-08-03
- Completion
- 2020-10-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NCO-48 | Unknown | 2 mg | Oral |
| Subject | NCO-48 | Unknown | 10 mg | Oral |
| Subject | NCO-48 | Unknown | 30 mg | Oral |
| Subject | NCO-48 | Unknown | 60 mg | Oral |
| Subject | NCO-48 | Unknown | 120 mg | Oral |
| Subject | NCO-48 | Unknown | 240 mg | Oral |