Study in Healthy Adults to Evaluate the Bioavailability of Two Test Tablet Formulations of ABT-450

Abbott

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ritonavir; Drug: ABT-450

Study type: Interventional

Funder types: Industry

Identifiers

NCT01091649

M10-797

Details and patient eligibility

About

The objective of this study is to assess the relative bioavailability of two test tablet formulations of ABT-450 as compared to the ABT-450 hard gelatin capsule formulation as a reference.

Full description

This is a two part study. Part 1 is a single dose, three period, complete crossover study in approximately 21 subjects. Part 2 is a single dose, two period, complete crossover study in approximately 20 subjects.

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Overall healthy subjects
• Non-childbearing potential females included

Exclusion Criteria

• Positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab
• Clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder
• Use of tobacco or nicotine-containing products with the 6-month period prior to study drug administration
• Abnormal screening laboratory results that are considered clinically significant by the investigator
• Pregnant or breastfeeding female; requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis
• Previous exposure to ABT-450

Trial design

40 participants in 5 patient groups

A

Active Comparator group

Description:

Low dose ABT-450 capsule and ritonavir capsules (reference).

Treatment:

Drug: ABT-450

Drug: ABT-450

Drug: ritonavir

B

Active Comparator group

Description:

Low dose ABT-450 SDD Tablet Form 1 and ritonavir capsules (test 1)

Treatment:

Drug: ABT-450

Drug: ABT-450

Drug: ritonavir

C

Active Comparator group

Description:

Low dose ABT-450 SDD Tablet Form 2 and ritonavir capsules (test 2).

Treatment:

Drug: ABT-450

Drug: ABT-450

Drug: ritonavir

D

Active Comparator group

Description:

High dose ABT-450 capsule and ritonavir capsules (reference).

Treatment:

Drug: ABT-450

Drug: ABT-450

Drug: ritonavir

E

Active Comparator group

Description:

High dose ABT-450 SDD Tablet Form 1 or 2 and ritonavir capsule (test)

Treatment:

Drug: ABT-450

Drug: ABT-450

Drug: ritonavir