Phase 1
N=47
AZD8848 Single Ascending Dose Study
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01560234 ↗Enrolled (actual)
47
Serious AEs
2.3%
Results posted
Jun 2016
Primary outcome: Primary: Adverse Events — 6; 2; 1; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- AZD8848 (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
6; 2; 1; 0; 3; 1 | — |
| PRIMARY Summary for Lymphocytes Laboratory Results |
1.6; 1.7; 2.0; 2.1; 2.3; 2.1 | — |
| SECONDARY Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC (Nmol*h/L) |
0.149; 0.360; 0.312; 0.642 | — |
| SECONDARY Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC(0-t) (Nmol*h/L) |
0.131; 0.328; 0.279; 0.591 | — |
| SECONDARY Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - Cmax (Nmol/L) |
0.0362; 0.0903; 0.473; 0.963; 0.629; 1.67 | — |
| SECONDARY Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma |
1.009; 0.9669; 0.9256; 1.134; 1.211; 1.036 | — |
| SECONDARY Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma |
1.009; 0.9669; 0.9256; 1.134; 1.211; 1.036 | — |
| SECONDARY Statistical Assessment of CXCL10 Ratio-to-baseline- Sputum |
1.038; 1.192; 0.8500; 0.8465; 3.160; 2.012 | — |
Summary
This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of AZD8848 in healthy subjects.
Eligibility Criteria
Inclusion Criteria
- Healthy men or women aged 18 to 45 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
- Women can be of childbearing potential and must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 (screening) and be willing to continue on the chosen contraceptive method
- Male subjects should be willing to use a condom (with spermicide) to prevent pregnancy and drug exposure of a female partner and refrain from donating sperm or fathering a child from the day of the investigational product administration until 3 months
- Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
- Ability to produce sputum of good enough quality for assessment of biomarkers
Exclusion Criteria
- Abnormal vital signs, after 10 minutes supine rest, defined as any of the following (SBP > 140 mmHg, Diastolic blood pressure (DBP) > 90 mmHg, Heart rate 85 beats per minute)
- Prolonged QTcF > 450 ms or shortened QTcF < 340 ms or family history of long QT syndrome
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class as AZD8848
- History of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalaemia, family history of Long QT syndrome, or sudden death)
- History of asthma or allergic rhinitis
Data sourced from ClinicalTrials.gov (NCT01560234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.