A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072 Used to Treat Hepatitis C - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00890318

Purpose

The purpose of this study is to determine multiple dose safety, tolerability and pharmacokinetics of ABT-072 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of ketoconazole on steady state ABT-072 pharmacokinetics.

Condition	Intervention	Phase
HCV Infection	Drug: ABT-072 Other: ketoconazole Drug: Placebo	Phase I

MedlinePlus related topics: Hepatitis C

Drug Information available for: Ketoconazole Fungarest

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment

Further study details as provided by Abbott:

Primary Outcome Measures:

Analysis of pharmacokinetic results. [ Time Frame: Study Days 1-11 ] [ Designated as safety issue: No ]
Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs. [ Time Frame: Study Days -2 through 11 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Analysis of single dose administration of ketocanozole on steady state ABT-072 pharmacokinetics. [ Time Frame: Study Day 11-13 ] [ Designated as safety issue: No ]

Estimated Enrollment:	32
Study Start Date:	April 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Healthy volunteers, receiving daily dose of 80 mg ABT-072 or placebo, QD for 10 days; and on Study Day 11 receiving a single dose of 80 mg ABT-072 or placebo + 400 mg ketoconazole	Drug: ABT-072 Powder contents from capsules mixed in an alternative vehicle, for additional information refer to Arm Description. Other: ketoconazole Tablet, see Arm Description for intervention information. Drug: Placebo Capsule or powder drug substance from the capsule mixed in an alternative vehicle, for additional information refer to Arm Description.
2 Healthy volunteers, receiving 160 mg ABT-072 or placebo, QD for 10 days.	Drug: ABT-072 Powder contents from capsules mixed in an alternative vehicle, for additional information refer to Arm Description. Drug: Placebo Capsule or powder drug substance from the capsule mixed in an alternative vehicle, for additional information refer to Arm Description.
3 Healthy volunteers, receiving 320 mg ABT-072 or placebo, QD for 10 days.	Drug: ABT-072 Powder contents from capsules mixed in an alternative vehicle, for additional information refer to Arm Description. Drug: Placebo Capsule or powder drug substance from the capsule mixed in an alternative vehicle, for additional information refer to Arm Description.

Detailed Description:

Phase 1, Blinded, Randomized, Placebo-controlled Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Main Selection Criteria for Healthy Volunteers:
- Subject has provided written consent.
- Subject is in general good health.
- If female, subject is postmenopausal for at least 2 years or surgically sterile.
- If female, subject is not pregnant and is not breast-feeding.
- Male or female between 18 and 55 years old, inclusive.
- If male, subject must be surgically sterile or practicing at least 1 method of birth control.
- Body Mass Index (BMI) is 18 to 29, inclusive.

Exclusion Criteria:

Use of medications including over the counter and vitamines.
Abuse of alcohol, drugs, or nicotine.
Current diseases or disorders.
History of cardiac disease.
If after consideration by the investigator, for any reason, that you are unsuitable to receive ABT-072.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890318

Contacts

Contact: Renee Heuser

847-938-5887

renee.heuser@abbott.com

Locations

United States, Illinois
Global Medical Information
Abbott Park, Illinois, United States, 60064

Sponsors and Collaborators

Abbott

More Information

No publications provided

Responsible Party:	Abbott ( Daniel Cohen, MD/Study Medical Director )
Study ID Numbers:	M10-705
Study First Received:	April 27, 2009
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00890318 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hepatitis
Clotrimazole
Miconazole
Antifungal Agents

Tioconazole
Healthy
Hepatitis C
Ketoconazole

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Antifungal Agents

Ketoconazole
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009