Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine Regimens in Adult Participants Hospitalized With Respiratory Syncytial Virus
Summary
The purpose of this study is to characterize the Pharmacokinetic and to confirm the popPK model derived from healthy volunteers in hospitalized adults who are infected with respiratory syncytial virus (RSV) and to determine in adults who are hospitalized with respiratory syncytial virus (RSV) infection the dose response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal RSV shedding using quantitative real-time reverse transcriptase-polymerase chain reaction (qRT-PCR) assay.
Timeline
- Start
- 2016-10-25
- Primary completion
- 2018-07-17
- Completion
- 2018-07-17
Outcome
Missed primary endpoint
Stopped (Business): “sponsor decision”
registry analysis (superiority test); Placebo vs 750 mg LD / 250 mg MD Lumicitabine; AUC(1-7) difference vs (pooled) placebo -0.32 (95% CI -0.89 to 0.24) NCT02935673 ↗
registry analysis (superiority test); Placebo vs 1000 mg LD / 500 mg MD Lumicitabine; AUC(1-7) difference vs (pooled) placebo -0.36 (95% CI -1.33 to 0.62) NCT02935673 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lumicitabine | Small molecule | 250 mg | Oral |
| Subject | Lumicitabine | Small molecule | 500 mg | Oral |