NCT02052362

CompletedPhase 1

Bioavailability of ABT-450 and ABT-267 With Ritonavir

AbbVie Source

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Other study identifiers

Sponsor study identifier

M14-229

Secondary identifiers

2013-003685-14

EUDRACT_NUMBER

Study Type

interventional

Actual enrollment (reported)

16

Locations

1 country

Sites

1

Timeline

Study Start

January 2014

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2014

Actual (reported)

Study Completion

February 2014

Actual (reported)

Brief Summary

A study to investigate the fraction of ABT-267 and ABT-450 absorbed by the body when given in combination with each other and Ritonavir(r).

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 16 participants
Study completion date: February 2014
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2014
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
January 30, 2014
Actual (reported)
Primary Completion
February 2014
Actual (reported)
Study Completion
February 2014
Actual (reported)
First Posted
February 3, 2014
Actual (reported)

Last Updated: February 19, 2014
Status Verified: February 2014
Last Update Submitted: February 17, 2014

Conditions

Absolute Bioavailability

Keywords

absolute bioavailabilityhealthy volunteers

Outcome Measures

Primary Outcomes (1)

Absolute bioavailability
dose normalized AUC(0-inf) for oral dose/dose normalized AUC(0-inf) for IV dose
Day 1 until 72 hours after single dose of ABT-450/r/ABT-267

Secondary Outcomes (4)

Safety Labs
Day -1 until 72 hours after single dose of ABT-450/r/ABT-267
Electrocardiograms (ECGs)
Day-1 until 24 hours after single dose of ABT-450/r/ABT-267
Number of participants with adverse events
Screening until 7 days after single dose of ABT-450/r/ABT-267
Physical Exam
Day-1 until 72 hours after single dose ABT-450/r/ABT-267

Study Arms (2)

Group 1 - Regimen A

EXPERIMENTAL

8 Subjects in Group I - Regimen A: ABT-450/r/ABT-267

Drug: ABT-450/r/ABT-267

Group 2 - Regimen B

EXPERIMENTAL

8 Subjects in Group II - Regimen B: ABT-450/r/ABT-267

Drug: ABT-450/r/ABT-267

Interventions

ABT-450/r/ABT-267Drug

ABT-450, ABT-267 and ritonavir

Group 1 - Regimen AGroup 2 - Regimen B

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Healthy males or non-pregnant, non-lactating healthy females
Body mass index of 18.0 to 30.0 kg/m2

Sponsors & Collaborators

AbbVie
Industrylead

Study Sites (1)

Site Reference ID/Investigator# 118615

Nottingham, NG11 6JS, United Kingdom

Study Officials

Armen Asatryan, MD
AbbVie
STUDY DIRECTOR

Enrollment

16 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 30, 2014

First Posted

February 3, 2014

Study Start

January 2014

Date type not reported

This date has not been verified as actual or estimated.

Phase 3

Completed

NCT02167945

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Phase 3Completed

NCT02219490

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Phase 3Completed

NCT01911845

An Open-label, Single Arm, Phase 2 Study to Evaluate ABT-450/r/ABT-267 and ABT-333 With Ribavirin (RBV) in Adults With Genotype 1 HCV Infection Taking Methadone or Buprenorphine

Phase 2Completed

NCT02517528

ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-Administered With Ribavirin (RBV) in Treatment Naïve and Treatment Experienced Asian Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Compensated Cirrhosis

Phase 3Completed

NCT01939197

A Multipart, Open-label Study to Evaluate the Safety and Efficacy of ABT-450/r/ABT-267 With and Without ABT-333 Coadministered With and Without Ribavirin in Adult With Genotype 1 or 4 Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 Coinfection

Phase 2/3Completed

Must be willing and able to communicate and participate in the whole study

Must provide written informed consent

Must agree to use an adequate method of contraception

In a condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG

You may not qualify if:

Participation in a clinical research study within the previous 3 months or in an absorption, distribution, metabolism, and excretion (ADME) study within the previous 12 months
History of any drug or alcohol abuse in the past 2 years or current smokers and those who have smoked within the last 12 months or a positive cotinine urine test at screening and admission
Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
Donation or loss of greater than 550 mL of blood (including plasmapheresis) or receipt of a transfusion of any blood product within the previous 8 weeks
Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies within the 14 days or any drug by injection (including vaccines) within 30 days or within 10 half-lives of the respective medication, whichever is longer, before Investigational Medical Product (IMP) administration

Contact the study team to confirm eligibility.

Primary Completion

February 2014

Actual (reported)

Study Completion

February 2014

Actual (reported)

Last Updated

February 19, 2014

Record last verified: 2014-02

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02052362
Data provider: ClinicalTrials.gov
Source updated: 2014-02-19
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:18:07 UTC

Locations

GB(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

Primary Completion

Study Completion

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Group 1 - Regimen A

Group 2 - Regimen B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations