Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01332903 | Open Label, Healthy Volunteers, ADME Study With Single Oral Administration of [14C] AZD5069 | PHASE1 | COMPLETED | 6 | — | — | May 1, 2011 | Jul 1, 2011 | Jun 25, 2015 | 1 | United Kingdom |
| NCT01100047 | Japanese Single and Multiple Ascending Dose (JSMAD), Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) Study of AZD5069 | PHASE1 | COMPLETED | 63 | — | — | May 1, 2010 | Feb 1, 2011 | Jun 25, 2015 | 1 | United Kingdom |
| NCT01051505 | A Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Multiple Ascending Doses of AZD5069 in Healthy Volunteers | PHASE1 | COMPLETED | 8 | — | — | Jan 1, 2010 | Apr 1, 2010 | Jun 25, 2015 | 1 | United Kingdom |
| NCT00953888 | Study to Investigate the Safety, Tolerability and Activity of AZD5069 When Given as a Single Dose to Healthy Male and/or Female Subjects | PHASE1 | COMPLETED | 203 | — | — | Jul 1, 2009 | Dec 1, 2009 | Jun 25, 2015 | 1 | United Kingdom |
To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring the amount of \[14C\] radioactivity in plasma and whole blood and the resulting area under the concentration-time curve from zero extrapolated to infinity (AUC), to the last measurable concentration (AUC(0 t)).
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | \[14C\] AZD5069 |
| 2 | PLACEBO_COMPARATOR | - |
| Active | EXPERIMENTAL | AZD5069 oral solution |
| Placebo | PLACEBO_COMPARATOR | Placebo oral solution |
| Name | Type | Description |
|---|---|---|
| [14C] AZD5069 | DRUG | Single 120 mg oral dose administered on Day 1 |
| AZD5069 | DRUG | Oral suspension |
| Placebo | DRUG | Oral suspension |
Inclusion Criteria: * Have a body mass index (BMI) of ≥18 and ≤30 kg/m2 and weight of ≥50 kg and ≤100 kg. * Regular daily bowel movements (ie, production of at least 1 stool per day). * Non-smoker or ex-smoker who has not used tobacco or nicotine products for ≥6 months prior to Visit 1 * Healthy Ma...