A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ABT-333

Abbott

Status and phase: Completed; Phase 1

Conditions: HCV Infection

Treatments: Drug: ketoconazole; Drug: ABT-333; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00768690

M10-687

Details and patient eligibility

About

The purpose of this study is to determine multiple dose safety, tolerability and pharmacokinetics of ABT-333 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of ketoconazole on steady state ABT-333 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-333

Enrollment: 45 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

• See above for main selection criteria

Trial design

45 participants in 5 patient groups

1

Other group

Description:

Healthy volunteers, receiving daily doses of 200 mg ABT-333 or placebo, BID for 10 days; and on Study Day 11 receiving a single dose of 200 mg ABT-333 or placebo + 400 mg ketoconazole

Treatment:

Drug: placebo

Drug: ketoconazole

Drug: ABT-333

2

Other group

Description:

Healthy volunteers, receiving 400 mg ABT-333 or placebo, BID

Treatment:

Drug: placebo

Drug: ABT-333

3

Other group

Description:

Healthy volunteers, receiving 600mg ABT-333 or placebo, BID

Treatment:

Drug: placebo

Drug: ABT-333

4

Other group

Description:

Healthy volunteers, receiving 1000mg ABT-333 or placebo, BID

Treatment:

Drug: placebo

Drug: ABT-333

5

Other group

Description:

Healthy volunteers, receiving 1600mg ABT-333 or placebo, BID\* \*After review of the data from previous groups, and in accordance with the protocol, this arm was not dosed.

Treatment:

Drug: placebo

Drug: ABT-333