Phase 1
Completed N=32
Relative Bioavailability of of Olodaterol and Ketoconazole
Healthy · Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01153711 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcomePrimary: Area Under Curve From 0 to 1 Hour at Steady State (AUC0-1,ss) — 2.512; 4.231 Picogram*hours/milliliter — p=1.0000
Summary
This clinical trial is intended to investigate a possible effect of the p-gp inhibitor ketoconazole on the bioavailability of olodaterol
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under Curve From 0 to 1 Hour at Steady State (AUC0-1,ss) |
2.512; 4.231 | 1.0000 |
| PRIMARY Maximum Concentration at Steady State (Cmax,ss) |
3.113; 5.169; 5.125; 5.465 | 1.0000 |
| SECONDARY Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss) |
0.250; 0.333; 4.00; 3.01 | — |
| SECONDARY Fraction of Urine Excretion From 0 to 24 Hours at Steady State (fe0-24,ss) |
4.29; 6.19 | — |
| SECONDARY Amount of the Analyte Excreted in Urine From 0 to 24 Hours at Steady State (Ae0-24,ss) |
428.972; 618.716; 445.266; 591.620 | 0.9986 |
| SECONDARY Area Under Curve From 0 to 8 Hours at Steady State (AUC0-8,ss) |
27.868; 28.076 | 0.0001 sig |
| SECONDARY Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG |
0; 0 | — |
| SECONDARY Assessment of Tolerability by the Investigator |
32; 32; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion criteria Healthy male and female volunteers
Exclusion criteria
Data sourced from ClinicalTrials.gov (NCT01153711). 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. Informational only — not medical advice.