A Study of Single Doses of ABT-072 in Japanese Healthy Male Adults
This study has been completed.
Sponsor:
Abbott
Collaborator:
Abbott Japan Co.,Ltd
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01081483
First received: March 4, 2010
Last updated: October 22, 2010
Last verified: September 2010
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Purpose
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of blinded, single ascending oral doses of ABT 072 under non-fasting conditions in healthy adult Japanese male subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C |
Drug: ABT-072 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Blinded, Randomized, Placebo-controlled Phase 1 Study in Healthy Male Adults to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles of Single Doses of ABT-072 |
Resource links provided by NLM:
Further study details as provided by Abbott:
Primary Outcome Measures:
- Safety and tolerability assessment [ Time Frame: Day 1 to Day 4 and Day 15. ] [ Designated as safety issue: Yes ]Safety and tolerability assessment by the evaluation of vital signs, ECGs, physical exams, clinical lab testing and adverse event monitoring.
- Pharmacokinetic profile evaluation [ Time Frame: Day 1 to Day 4 ] [ Designated as safety issue: No ]Single Dose Pharmacokinetic profile evaluation
| Enrollment: | 24 |
| Study Start Date: | March 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: ABT-072 Tablet
ABT-072 50 mg Tablet, every day (QD), single ascending doses, groups 1-3
|
Drug: ABT-072
See arm description for more information
Other Name: ABT-072
|
|
Placebo Comparator: Placebo
Placebo Tablet, QD, single doses, groups 1-3
|
Drug: Placebo
See arm description for more information
Other Name: Placebo
|
Eligibility| Ages Eligible for Study: | 20 Years to 50 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Overall healthy adult Japanese males
Exclusion Criteria:
- Use of any medications (prescription and over-the-counter), vitamins, or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication, whichever is longer.
- Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or HIV antibodies (HIV Ab).
- Positive screen for drugs of abuse, alcohol, or cotinine.
- 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 preceding study drug administration.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Kazuhiko Sawa, Abbott Japan Co., Ltd |
| ClinicalTrials.gov Identifier: | NCT01081483 History of Changes |
| Other Study ID Numbers: | M11-310 |
| Study First Received: | March 4, 2010 |
| Last Updated: | October 22, 2010 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Abbott:
|
Healthy Volunteers HCV Infections |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on May 23, 2013