A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072 Used to Treat Hepatitis C

Abbott

Status and phase: Completed; Phase 1

Conditions: HCV Infection

Treatments: Drug: Placebo; Drug: ABT-072; Other: ketoconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00890318

M10-705

Details and patient eligibility

About

The purpose of this study is to determine multiple dose safety, tolerability and pharmacokinetics of ABT-072 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of ketoconazole on steady state ABT-072 pharmacokinetics.

Full description

Phase 1, Blinded, Randomized, Placebo-controlled Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Main Selection Criteria for Healthy Volunteers:

  • Subject has provided written consent.
  • Subject is in general good health.
  • If female, subject is postmenopausal for at least 2 years or surgically sterile.
  • If female, subject is not pregnant and is not breast-feeding.
  • Male or female between 18 and 55 years old, inclusive.
  • If male, subject must be surgically sterile or practicing at least 1 method of birth control.
  • Body Mass Index (BMI) is 18 to 29, inclusive.

Exclusion criteria

• Use of medications including over the counter and vitamines.
• Abuse of alcohol, drugs, or nicotine.
• Current diseases or disorders.
• History of cardiac disease.
• If after consideration by the investigator, for any reason, that you are unsuitable to receive ABT-072.

Trial design

32 participants in 3 patient groups

1

Other group

Description:

Healthy volunteers, receiving daily dose of 80 mg ABT-072 or placebo, QD for 10 days; and on Study Day 11 receiving a single dose of 80 mg ABT-072 or placebo + 400 mg ketoconazole

Treatment:

Drug: ABT-072

Drug: Placebo

Other: ketoconazole

2

Other group

Description:

Healthy volunteers, receiving 160 mg ABT-072 or placebo, QD for 10 days.

Treatment:

Drug: ABT-072

Drug: Placebo

3

Other group

Description:

Healthy volunteers, receiving 320 mg ABT-072 or placebo, QD for 10 days.

Treatment:

Drug: ABT-072

Drug: Placebo