NCT00850044

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Last Updated

November 20, 2017

Status Verified

September 1, 2010

Enrollment Period

5 months

First QC Date

February 20, 2009

Last Update Submit

November 16, 2017

Conditions

HCV Infection

Keywords

FIHSAD

Outcome Measures

Primary Outcomes (2)

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

    4 days

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

    10 days

Study Arms (4)

1

ACTIVE COMPARATOR

ABT-450

Drug: ABT-450

2

PLACEBO COMPARATOR

Placebo for ABT-450

Drug: placebo for ABT-450

3

ACTIVE COMPARATOR

ABT-450/ritonavir

Drug: ABT-450Drug: ritonavir

4

PLACEBO COMPARATOR

Placebo for ABT-450/placebo for ritonavir

Drug: placebo for ABT-450Drug: Placebo for ritonavir

Interventions

ABT-450DRUG

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

13
ritonavirDRUG

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

Also known as: ABT-538, Norvir
3
placebo for ABT-450DRUG

capsules, QD, one dose

Also known as: placebo
24
Placebo for ritonavirDRUG

capsules, QD, one dose

Also known as: placebo
4

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • overall healthy subjects
  • non-childbearing potential females included

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site Reference ID/Investigator# 15981

Waukegan, Illinois, 60085, United States

Location

Related Publications (1)

  • 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.

    PMID: 26710243RESULT

MeSH Terms

Conditions

Hepatitis C

Interventions

paritaprevirRitonavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Adebayo A Lawal, MD

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 20, 2009

First Posted

February 24, 2009

Study Start

February 1, 2009

Primary Completion

July 1, 2009

Last Updated

November 20, 2017

Record last verified: 2010-09

Locations

US(1)