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Safety, Tolerability and PK Study of Single Doses of ABT-450 With and Without Ritonavir to Treat Hepatitis C Virus (HCV) Genotype 1

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 FIH, SAD

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 with the 6-month period prior to study drug administration
donation or loss of 550 mL 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# 15981

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Arm Description

ABT-450

Placebo for ABT-450

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

NCT00850044

First Posted

February 20, 2009

Last Updated

November 16, 2017

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT00850044

Brief Title

Safety, Tolerability and PK Study of Single Doses of ABT-450 With and Without Ritonavir to Treat Hepatitis C Virus (HCV) Genotype 1

Official Title

A Double-Blind, Randomized, Placebo-Controlled, Nonfasting Study in Healthy Adults to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Single Doses of ABT-450 With and Without Ritonavir

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

AbbVie

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine the pharmacokinetic and safety profiles of an experimental HCV protease inhibitor with and without ritonavir in healthy volunteers.

6. Conditions and Keywords

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

HCV Infection

Keywords

FIH, SAD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

87 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

ABT-450

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo for ABT-450

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, one dose, see Arm Descriptions for more information

Intervention Type

Drug

Intervention Name(s)

ritonavir

Other Intervention Name(s)

ABT-538, Norvir

Intervention Description

capsules, QD, one dose, escalating doses, see Arm Descriptions for more information

Intervention Type

Drug

Intervention Name(s)

placebo for ABT-450

Other Intervention Name(s)

placebo

Intervention Description

capsules, QD, one dose

Intervention Type

Drug

Intervention Name(s)

Placebo for ritonavir

Other Intervention Name(s)

placebo

Intervention Description

capsules, QD, one dose

Primary Outcome Measure Information:

Title

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

Time Frame

4 days

Title

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

Time Frame

10 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 with the 6-month period prior to study drug administration donation or loss of 550 mL 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

Adebayo A Lawal, MD

Organizational Affiliation

Abbott

Official's Role

Study Director

Facility Information:

Facility Name

Site Reference ID/Investigator# 15981

City

Waukegan

State/Province

Illinois

ZIP/Postal Code

60085

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26710243

Citation

Menon RM, Klein CE, Podsadecki TJ, Chiu YL, Dutta S, Awni WM. Pharmacokinetics and tolerability of paritaprevir, a direct acting antiviral agent for hepatitis C virus treatment, with and without ritonavir in healthy volunteers. Br J Clin Pharmacol. 2016 May;81(5):929-40. doi: 10.1111/bcp.12873. Epub 2016 Feb 24.

Results Reference

result

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Safety, Tolerability and PK Study of Single Doses of ABT-450 With and Without Ritonavir to Treat Hepatitis C Virus (HCV) Genotype 1

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