A Phase-1, Single Center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics (Including Food Effect) of Ascending Oral Doses of AZD5847 in Healthy Male Subjects and Female Subjects of Non-childbearing Potential
Overview
- Phase
- Phase 1
- Intervention
- Placebo to AZD5847
- Conditions
- Healthy
- Sponsor
- AstraZeneca
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Safety and tolerability of AZD5847 administered orally will be assessed by incidence and severity of AE's, abnormalities in vital sign assessments, ECG's, telemetry, clinical laboratory assessments, physical exams and withdrawals
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
The main purpose of this study is to assess the safety and tolerability of AZD5847 after receiving oral doses on a single day (Part A) or after receiving a single oral dose in two periods (Part B). For volunteers in Part B, the effect of food on the PK of AZD5847 will also be studied. Another purpose is to evaluate the pharmacokinetics (PK) of AZD5847 and its metabolites in blood and urine.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Provision of signed and dated, written informed consent prior to any study specific procedures
- •Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG.
- •Healthy male and female volunteers. Females must be of non childbearing potential
Exclusion Criteria
- •Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 4 weeks of the first administration of the Investigational Product
- •History of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
Arms & Interventions
Placebo to AZD5847
Placebo
Intervention: Placebo to AZD5847
AZD5847 oral suspension
Active
Intervention: AZD5847
Outcomes
Primary Outcomes
Safety and tolerability of AZD5847 administered orally will be assessed by incidence and severity of AE's, abnormalities in vital sign assessments, ECG's, telemetry, clinical laboratory assessments, physical exams and withdrawals
Time Frame: Safety assessments are taken prior to and after drug administration. Volunteers will be monitored througout the study for adverse events.
Secondary Outcomes
- To characterize the pharmacokinetics of AZD5847 in blood and urine following oral doses.(Samples taken during the residential period at defined timepoints pre-dose and post-dose.)
- To assess the effect of food on the pharmacokinetics of AZD5847 following oral administration of AZD5847(Samples taken during the residential period at defined timepoints pre-dose and post-dose)