Safety Study of Single Oral Doses of VBY-036 in Healthy Volunteers (VBY036P1A)

NCT01911637 | Completed Phase 1 DMC

• 1 other identifier: VBY-036-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

VBY-036 may treat or prevent nerve pain. This study aims to find the highest safe and tolerable single dose of VBY-036 in healthy volunteers. Volunteers are randomly selected to receive one dose of either a placebo or VBY-036 (10, 30, 100, 300, 600 or 900 mg).

Conditions

Healthy

Keywords

Healthy; Subjects; Safety; Tolerability; VBY-036; Maximum; Pharmacodynamic; Pharmacokinetic

Outcome Measures

Primary Outcomes (1)

• Highest safe and tolerated VBY-036 dose

  Single dose of VBY-036 given one day for each cohort in an ascending manner. Cohort A1 with 10 mg dose or placebo; Cohort A2 with 30 mg dose or placebo; Cohort A3 with 100 mg dose or placebo; Cohort A4 with 300 mg dose or placebo; Cohort A5 with 600 mg dose or placebo; Cohort A6 with 900 mg dose or placebo

  5-days assessment

Secondary Outcomes (1)

• Confirmation of cathepsin-S inhibition

  2 days

Other Outcomes (1)

• The blood level of VBY-036

  4 days

Study Arms (2)

VBY-036

EXPERIMENTAL

VBY-036 10 mg, 30 mg, 100 mg, 300 mg, 600 mg, or 900 mg

Drug: VBY-036; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo

Drug: VBY-036; Drug: Placebo

Interventions

VBY-036 DRUG

Study drug VBY-036

Also known as: Cathepsin S inhibitor

Placebo; VBY-036

Placebo DRUG

Placebo

Placebo; VBY-036

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, 18-60 years old
• Screening body mass index between 18-32 kg/m2
• Good health, no clinically significant findings in medical history, 12-lead ECG, \& vital signs;
• Clinical lab evaluations (Chem panel \[fasted at least 8 hrs\], CBC, HbA1c \& UA in reference range for test lab (unless deemed not clinically significant);
• Negative test for drugs of abuse at Screening \& at Check-in (includes alcohol);
• Negative hepatitis, HIV \& TB screens;
• Females non-pregnant, non-lactating, \& either postmenopausal for at least 1 year, surgically sterile for at least 90 days prior to Check-in, or agree to use from the time of consent until 90 days after Study Completion an effective form of contraception. For all females, a pregnancy test result must be negative at Screening \& Check-in.
• Males will be sterile or agree to use from Check-in until 90 days following discharge an effective method of contraception.
• Able to comprehend \& willing to sign Informed Consent Form

You may not qualify if:

• Females pregnant or nursing, or childbearing potential but unwilling to use contraception.
• History of renal or hepatic impairment; stomach or intestinal surgery or resection, malabsorption syndrome, cholecystectomy, or gastro-intestinal dysfunction that would alter absorption \&/or excretion of orally administered drugs (appendectomy or hernia repair allowed);
• Anemia (hemoglobin \<11.5 g/dL for females; \< 13 g/dL for males) or blood donation within 8 weeks of Check-in;
• Plasma donation within 4 weeks of Check-in;
• History of alcoholism or drug addiction within 6 months to Check-in;
• Use of drugs of abuse or prescription drugs for recreational use 6 months prior to Check-in;
• Use of any tobacco-containing or nicotine-containing products 6 months prior to Check-in \& during study;
• Participation in another drug trial 30 days of Check-in (within 8 weeks if previous investigational drug has immunomodulary effects, other than cathepsin S inhibition);
• History or clinical manifestations of metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders
• History of hypersensitivity or allergies to any drug compound
• History or presence of abnormal ECG
• Laboratory abnormality deemed clinically significant;
• Use of or inability to discontinue any prescription medications/products 14 days prior to Check-in \& during study;
• Use of certain over-the-counter, non-prescription preparations are permitted up to 3 days before first dose;
• Use of alcohol-containing, grapefruit-containing, star fruit containing foods or beverages or "energy drinks" 72 hours to Check-in \& during study;

Sponsors & Collaborators

• Virobay Inc.: lead

Study Sites (1)

Covance Evansville

Evansville, Indiana, 47710, United States

Location

Study Officials

• David B. Karpf, MD

  Virobay Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2013
• First Posted: July 30, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 31, 2013

Record last verified: 2013-12

Locations

US (1)