Back to results

Study in Healthy Adults to Evaluate Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir

Primary Purpose

HCV Infection

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ABT-450

ritonavir

Placebo for ABT-450

Placebo for ritonavir

About this trial

This is an interventional treatment trial for HCV Infection focused on measuring Multiple Ascending Doses

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

overall healthy subjects
non-childbearing potential females included

Exclusion Criteria:

history of significant sensitivity to any drug
positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab
history of gastrointestinal issues or procedures
history of seizures, diabetes or cancer (except basal cell carcinoma)
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 within the 6-month period prior to study drug administration
donation or loss of 550mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration
abnormal screening laboratory results that are considered clinically significant by the investigator
current enrollment in another clinical study
previous enrollment in this study
recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol
pregnant or breastfeeding female
requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis

Sites / Locations

Site Reference ID/Investigator# 18161

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

ABT-450/ritonavir

Placebo for ABT-450/placebo for ritonavir

Outcomes

Primary Outcome Measures

Pharmacokinetics (blood draws, pre- and post-dose)

Safety and Tolerability (ECGs, AEs, vitals, physical exams, routine labs)

Secondary Outcome Measures

Full Information

NCT ID

NCT00931281

First Posted

June 5, 2009

Last Updated

October 11, 2010

Sponsor

Abbott

1. Study Identification

Unique Protocol Identification Number

NCT00931281

Brief Title

Study in Healthy Adults to Evaluate Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir

Official Title

A Blinded, Randomized, Nonfasting, Placebo-Controlled Study in Healthy Adults to Evaluate Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Ascending Doses of ABT-450 With Ritonavir

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Abbott

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of multiple doses of an experimental hepatitis C virus (HCV) protease inhibitor with ritonavir in healthy volunteers.

Detailed Description

This is a multiple ascending dose, non-fasting, open label, randomized study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HCV Infection

Keywords

Multiple Ascending Doses

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

ABT-450/ritonavir

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo for ABT-450/placebo for ritonavir

Intervention Type

Drug

Intervention Name(s)

ABT-450

Intervention Description

capsules, QD or BID, 14 days, ascending doses

Intervention Type

Drug

Intervention Name(s)

ritonavir

Other Intervention Name(s)

ABT-538, Norvir

Intervention Description

capsules, QD or BID, 14 days, ascending doses

Intervention Type

Drug

Intervention Name(s)

Placebo for ABT-450

Other Intervention Name(s)

placebo

Intervention Description

capsule, QD or BID, 14 days

Intervention Type

Drug

Intervention Name(s)

Placebo for ritonavir

Other Intervention Name(s)

placebo

Intervention Description

capsule, QD or BID, 14 days

Primary Outcome Measure Information:

Title

Pharmacokinetics (blood draws, pre- and post-dose)

Time Frame

17 days

Title

Safety and Tolerability (ECGs, AEs, vitals, physical exams, routine labs)

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: overall healthy subjects non-childbearing potential females included Exclusion Criteria: history of significant sensitivity to any drug positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab history of gastrointestinal issues or procedures history of seizures, diabetes or cancer (except basal cell carcinoma) 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 within the 6-month period prior to study drug administration donation or loss of 550mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration abnormal screening laboratory results that are considered clinically significant by the investigator current enrollment in another clinical study previous enrollment in this study recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol pregnant or breastfeeding female requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Isabelle A Gaultier, M.S., IBMH

Organizational Affiliation

Abbott

Official's Role

Study Director

Facility Information:

Facility Name

Site Reference ID/Investigator# 18161

City

Waukegan

State/Province

Illinois

ZIP/Postal Code

60085

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Study in Healthy Adults to Evaluate Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir

We'll reach out to this number within 24 hrs