AZD8075 Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Oral Doses of AZD8075 in Healthy Male Volunteers

NCT00829127 | Withdrawn Phase 1

• 2 other identifiers: D3801C00004EudraCt No.2008-006550-17
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aims of the study are to evaluate the safety, tolerability and pharmacokinetics of AZD8075 in healthy male subjects at increasing doses when given for 14 days

Conditions

Healthy

Keywords

volunteers

Outcome Measures

Primary Outcomes (1)

• Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)

  daily

Secondary Outcomes (1)

• characterise the multiple dose PK of AZD8075 and assess the time required to reach steady state, the degree of accumulation and the time dependency of the PK

  daily

Study Arms (2)

1

EXPERIMENTAL

Drug: AZD8075

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AZD8075 DRUG

single dose, oral suspension, on Day 1. Repeated dosing will commence on Day 3 once daily for 14 days. The planned starting dose will be 35 mg with up to 2 dose escalations not exceeding AstraZeneca pre-defined upper exposure limits or the exposure obtained so far in the SAD study.

1

Placebo DRUG

Oral suspension

2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of signed, written and dated informed consent prior to any study specific procedures
• Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
• Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start

You may not qualify if:

• Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject's ability to participate
• Any clinically relevant abnormal findings in phys.examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline, which, in the opinion of the investigator, may put the subject at risk because of his participation in the study
• Participation in another investigational drug study within 3 months before Visit 2 or participation in a method development study (no drug) 1 month prior to Visit 2

Sponsors & Collaborators

• AstraZeneca: lead

Study Officials

• Eva Pettersson

  AstraZeneca R&D, Lund, Sweden

  STUDY DIRECTOR

• Wolfgang Kühn

  Quintiles, Uppsala, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2009
• First Posted: January 26, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: August 25, 2011

Record last verified: 2011-08