Phase 1
Completed N=64
Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects
Source: ClinicalTrials.gov NCT02061358 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcomePrimary: Subjects With Treatment-emergent Adverse Event (TEAEs) by Treatment Group — 5; 6; 5; 5 Subjects with at least 1 TEAE
Summary
The objective is to evaluate the safety and tolerability of a single-ascending oral dose of UV-4B in healthy subjects and to determine pharmacokinetic parameters describing absorption and elimination following a single dose of UV-4B in healthy subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects With Treatment-emergent Adverse Event (TEAEs) by Treatment Group |
5; 6; 5; 5; 6; 5 | — |
| PRIMARY Subjects With Serious Adverse Event (SAEs) by Treatment Group |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population) |
6; 6; 5; 5; 6; 5 | — |
| PRIMARY Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group |
3; 5; 5; 4; 4; 3 | — |
| SECONDARY Cmax by Treatment Group: UV-4 |
22.1; 82.6; 289; 900; 2060; 4490 | — |
| SECONDARY Tmax by Treatment Group: UV-4 |
0.50; 1.00; 0.50; 0.50; 0.75; 0.50 | — |
| SECONDARY AUC(0-last) by Treatment Group: UV-4 |
82.1; 406; 1230; 3640; 7050; 13600 | — |
| SECONDARY AUC(0-inf) by Treatment Group: UV-4 |
94.6; 420; 1260; 3700; 7090; 13700 | — |
| SECONDARY CL/F by Treatment Group: UV-4 |
31.7; 23.8; 23.9; 24.3; 25.4; 26.3 | — |
| SECONDARY Vz/F by Treatment Group: UV-4 |
470; 409; 344; 358; 317; 308 | — |
| SECONDARY t(1/2) by Treatment Group: UV-4 |
9.11; 11.6; 9.98; 9.56; 8.52; 8.14 | — |
| SECONDARY Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group |
0.607; 2.67; 10.6; 38.1; 77.5; 159 | — |
| SECONDARY Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group |
20.2; 26.7; 35.3; 42.2; 43.0; 44.2 | — |
| SECONDARY CLr by Treatment Group: UV-4 |
14.3; 11.4; 12.5; 13.6; 13.9; 13.7 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy subjects
- Women: non-pregnant, non-lactating; if of childbearing potential, on specified contraception measures during the study period
- Men: using barrier contraception measures during the study period
Exclusion Criteria
- Health conditions
- Taking prescription and non-prescription drugs (exceptions: acetaminophen, vitamins, hormonal birth control)
Data sourced from ClinicalTrials.gov (NCT02061358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.