Trial | NCT02415439  Report issue

Title

A Phase 1 Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VBP15 in Healthy Adult Subjects
A Phase 1 Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VBP15 in Healthy Adult Subjects

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Intervention/Treatment

    vamorolone ...

  • Study Participants

    86
The purpose of this study is to examine the safety, tolerability, and PK of various increasing single and multiple doses of VBP15 in healthy adult subjects.
Study Started
Jan 31
2015
Primary Completion
Nov 30
2015
Study Completion
May 31
2016
Results Posted
Jan 05
2017
Estimate
Last Update
Mar 10
2017

Drug VBP15

Drug Placebo

VBP15- 0.1 mg/kg SAD Experimental

Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.

VBP15- 0.3 mg/kg SAD Experimental

Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.

VBP15- 1.0 mg/kg SAD Experimental

Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.

VBP15- 3.0 mg/kg SAD Experimental

Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.

VBP15- 8.0 mg/kg Fasting SAD Experimental

Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.

VBP15- 8.0 mg/kg Fed SAD Experimental

Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high fat/high high calorie meal.

VBP15- 20.0 mg/kg SAD Experimental

Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions.

Placebo - SAD Placebo Comparator

Subjects were orally administered a placebo under fasted conditions.

VBP15- 1.0 mg/kg 14 Day MAD Experimental

Subjects were orally administered VBP15 at 1.0 mg/kg for 14 days under fasted conditions.

VBP15- 3.0 mg/kg 14 Day MAD Experimental

Subjects were orally administered VBP15 at 3.0 mg/kg for 14 days under fasted conditions.

VBP15- 9.0 mg/kg 14 Day MAD Experimental

Subjects were orally administered VBP15 at 9.0 mg/kg for 14 days under fasted conditions.

VBP15- 20.0 mg/kg 14 Day MAD Experimental

Subjects were orally administered VBP15 at 20.0 mg/kg for 14 days under fasted conditions.

Placebo MAD Placebo Comparator

Subjects were orally administered placebo for 14 days under fasted conditions.

Criteria 

Inclusion Criteria:

For the Single Ascending Dose Study (SAD): Male subjects, ages 18 to 65 years, inclusive.
For the Multiple Ascending Dose Study (MAD): Male subjects or female subjects of nonchildbearing potential ages 18 to 65, inclusive.

Exclusion Criteria:

For the MAD Study: Women of childbearing potential.
Clinically significant abnormal laboratory parameters

Summary

VBP15- 0.1 mg/kg SAD

VBP15- 0.3 mg/kg SAD

VBP15- 1.0 mg/kg SAD

VBP15- 3.0 mg/kg SAD

VBP15- 8.0 mg/kg Fasted SAD

VBP15- 8.0 mg/kg Fed SAD

VBP15- 20.0 mg/kg SAD

Placebo SAD

VBP15- 1.0 mg/kg 14 Days MAD

VBP15- 3.0 mg/kg 14 Days MAD

VBP15- 9.0 mg/kg 14 Days MAD

VBP15- 20.0 mg/kg 14 Days MAD

Placebo MAD

All Events

Event Type Organ System Event Term VBP15- 0.1 mg/kg SAD VBP15- 0.3 mg/kg SAD VBP15- 1.0 mg/kg SAD VBP15- 3.0 mg/kg SAD VBP15- 8.0 mg/kg Fasted SAD VBP15- 8.0 mg/kg Fed SAD VBP15- 20.0 mg/kg SAD Placebo SAD VBP15- 1.0 mg/kg 14 Days MAD VBP15- 3.0 mg/kg 14 Days MAD VBP15- 9.0 mg/kg 14 Days MAD VBP15- 20.0 mg/kg 14 Days MAD Placebo MAD

Number of Subjects With Adverse Effects After a Single Dose of VBP15

VBP15- 0.1 mg/kg SAD

2.0
participants

VBP15- 0.3 mg/kg SAD

1.0
participants

VBP15- 1.0 mg/kg SAD

1.0
participants

VBP15- 3.0 mg/kg SAD

1.0
participants

VBP15- 8.0 mg/kg Fasting SAD

VBP15- 8.0 mg/kg Fed SAD

1.0
participants

VBP15- 20.0 mg/kg SAD

Placebo SAD

Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose of VBP15 (0 Through 72 Hours Post Dose)

VBP15- 0.1 mg/kg SAD

42.0
(hr*ng/mL) (Mean)
Standard Deviation: 17

VBP15- 0.3 mg/kg SAD

161.0
(hr*ng/mL) (Mean)
Standard Deviation: 16

VBP15- 1.0 mg/kg SAD

486.0
(hr*ng/mL) (Mean)
Standard Deviation: 20

VBP15- 3.0 mg/kg SAD

1578.0
(hr*ng/mL) (Mean)
Standard Deviation: 21

VBP15- 8.0 mg/kg Fasted SAD

3997.0
(hr*ng/mL) (Mean)
Standard Deviation: 55

VBP15- 8.0 mg/kg Fed SAD

10139.0
(hr*ng/mL) (Mean)
Standard Deviation: 25

VBP15- 20.0 mg/kg SAD

8545.0
(hr*ng/mL) (Mean)
Standard Deviation: 30

Placebo SAD

Peak Plasma Concentration (Cmax) of VBP15 After a Single Dose of VBP15

VBP15- 20.0 mg/kg SAD

1648.0
(ng/mL) (Mean)
Standard Deviation: 17

Placebo SAD

VBP15- 0.1 mg/kg SAD

13.0
(ng/mL) (Mean)
Standard Deviation: 13

VBP15- 0.3 mg/kg SAD

51.0
(ng/mL) (Mean)
Standard Deviation: 17

VBP15- 1.0 mg/kg SAD

122.0
(ng/mL) (Mean)
Standard Deviation: 33

VBP15- 3.0 mg/kg SAD

305.0
(ng/mL) (Mean)
Standard Deviation: 24

VBP15- 8.0 mg/kg Fasting SAD

718.0
(ng/mL) (Mean)
Standard Deviation: 43

VBP15- 8.0 mg/kg Fed SAD

1817.0
(ng/mL) (Mean)
Standard Deviation: 31

Number of Subjects With Adverse Effects After 14 Daily Doses of VBP15

VBP15- 1.0 mg/kg 14 Days MAD

2.0
participants

VBP15- 3.0 mg/kg 14 Days MAD

VBP15- 9.0 mg/kg 14 Days MAD

VBP15- 20.0 mg/kg 14 Days MAD

2.0
participants

Placebo MAD

2.0
participants

Area Under the Plasma Concentration Versus Time Curve (AUC) After 14 Daily Doses of VBP15 (0 Through 72 Hours Post Dose)

VBP15- 1.0 mg/kg 14 Days MAD

794.0
(hr*ng/mL) (Mean)
Standard Deviation: 22

VBP15- 3.0 mg/kg 14 Days MAD

1494.0
(hr*ng/mL) (Mean)
Standard Deviation: 19

VBP15- 9.0 mg/kg 14 Days MAD

4366.0
(hr*ng/mL) (Mean)
Standard Deviation: 20

VBP15- 20.0 mg/kg 14 Days MAD

9309.0
(hr*ng/mL) (Mean)
Standard Deviation: 39

Placebo MAD

Peak Plasma Concentration (Cmax) of VBP15 After 14 Daily Doses of VBP15

VBP15- 1.0 mg/kg 14 Days MAD

153.0
(ng/mL) (Mean)
Standard Deviation: 16

VBP15- 3.0 mg/kg 14 Days MAD

281.0
(ng/mL) (Mean)
Standard Deviation: 37

VBP15- 9.0 mg/kg 14 Days MAD

1082.0
(ng/mL) (Mean)
Standard Deviation: 23

VBP15- 20.0 mg/kg 14 Days MAD

2416.0
(ng/mL) (Mean)
Standard Deviation: 51

Placebo MAD

Total

86
Participants

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

VBP15- 0.1 mg/kg SAD

VBP15- 0.3 mg/kg SAD

VBP15- 1.0 mg/kg SAD

VBP15- 3.0 mg/kg SAD

VBP15- 8.0 mg/kg Fasted SAD

VBP15- 8.0 mg/kg Fed SAD

VBP15- 20.0 mg/kg SAD

Placebo SAD

VBP15- 1.0 mg/kg 14 Day MAD

VBP15- 3.0 mg/kg 14 Day MAD

VBP15- 9.0 mg/kg 14 Day MAD

VBP15- 20 mg/kg 14 Day MAD

Placebo MAD