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

V

Virobay

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: VBY-036
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01911637
VBY-036-001

Details and patient eligibility

About

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).

Full description

Detailed description is noted in Brief Summary.

Enrollment

48 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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;
  • Poor peripheral venous access;
  • Receipt of blood products 6 months to Check-in
  • Subjects with history of Gilbert's Syndrome;
  • Strenuous activities 48 hours before receiving experimental or placebo comparator
  • Illness 5 days to drug administration
  • Any acute or chronic condition

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Triple Blind

48 participants in 2 patient groups, including a placebo group

VBY-036
Experimental group
Description:
VBY-036 10 mg, 30 mg, 100 mg, 300 mg, 600 mg, or 900 mg
Treatment:
Drug: Placebo
Drug: VBY-036
Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo
Drug: VBY-036

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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