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

NCT01091649 | Completed Phase 1

• 1 other identifier: M10-797
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Pharmacokinetics, Safety

Outcome Measures

Primary Outcomes (2)

• Assessment of Pharmacokinetics of two ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir. Each dosed at low ABT-450/ritonavir

  72 hrs post dose

• Assessment of Pharmacokinetics of the selected ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir. Each dosed at high ABT-450/ritonavir

  72 hrs post dose

Secondary Outcomes (1)

• To tabulate treatment emergent adverse events of two ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir

  Through 30 days post last dose.

Study Arms (5)

A

ACTIVE COMPARATOR

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

Drug: ABT-450; Drug: ritonavir

B

ACTIVE COMPARATOR

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

Drug: ABT-450; Drug: ritonavir

C

ACTIVE COMPARATOR

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

Drug: ABT-450; Drug: ritonavir

D

ACTIVE COMPARATOR

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

Drug: ritonavir; Drug: ABT-450

E

ACTIVE COMPARATOR

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

Drug: ritonavir; Drug: ABT-450

Interventions

ABT-450 DRUG

Low dose ABT-450 / ritonavir see Arm Description for more information

A; B; C

ritonavir DRUG

ritonavir see Arm Description for more information

Also known as: ABT-538, ritonavir, Norvir

A; B; C; D; E

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Overall healthy subjects
• Non-childbearing potential females included

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Site Reference ID/Investigator# 27781

Waukegan, Illinois, 60085, United States

Location

MeSH Terms

Interventions

paritaprevir; Ritonavir

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Adebayo Lawal, M.D.

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 26, 2010
• First Posted: March 24, 2010
• Study Start: February 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: December 21, 2010

Record last verified: 2010-09

Locations

US (1)