AZD3355 Dose-escalation Study in Healthy Males
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00757419
First received: September 22, 2008
Last updated: December 6, 2010
Last verified: December 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The aim is to establish the maximal tolerated dose of AZD3355 for the selection of doses in the up-coming studies. This will be done by comparing single and repeated doses of AZD3355 to placebo ("inactive substance"). Safety and tolerability variables will be closely monitored throughout the study.
| Condition | Intervention | Phase |
|---|---|---|
|
Reflux Disease |
Drug: AZD3355 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
| Official Title: | A Phase 1 Single Centre Single-blind Randomised Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD3355 After Administration of Single Ascending Doses and Multiple Repeated Doses in Healthy Male Volunteers |
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Safety variables (Adverse event reporting, ECG, blood pressure, pulse rate, urine weight and osmolality, body temperature, blood and urine laboratory values) [ Time Frame: During the study ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetic variables [ Time Frame: Several occasions during the study days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 54 |
| Study Start Date: | September 2008 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: AZD3355
capsules, oral, single or twice daily dose
Other Name: Lesogaberan
|
| Placebo Comparator: 2 |
Drug: Placebo
To match dosing of AZD3355
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Subjects without concurrent diseases who do not require any medical treatments
- Provision of signed informed consent.
Exclusion Criteria:
- History of somatic disease/condition, which may interfere with the objectives for the study, as judged by the investigator.
- Clinically significant illness or clinically relevant trauma within the 2 weeks prior to the administration of the investigational product, as judged by the investigator.
- History of clinically significant orthostatic reaction or syncope
- Clinically important abnormalities related to the heart function
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00757419
Locations
| Sweden | |
| Research Site | |
| Gothenburg, Sweden | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | Marianne Hartford | CPU Avd 102, Gröna Stråket 12, Sahlgrenska Universitetssjukhuset, 413 45 Göteborg |
| Study Director: | Eva Ersdal | AstraZeneca R&D, Mölndal, Sweden |
More Information
No publications provided
| Responsible Party: | Debra G. Silberg, MD, PhD, Medical Science Director, AZD3355, AstraZeneca Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00757419 History of Changes |
| Other Study ID Numbers: | D9120C00030, EudraCTnr: 2008-003578-16 |
| Study First Received: | September 22, 2008 |
| Last Updated: | December 6, 2010 |
| Health Authority: | Sweden: Medical Products Agency |
Keywords provided by AstraZeneca:
|
Safety tolerability healthy subjects |
ClinicalTrials.gov processed this record on May 16, 2013