Trial · NCT05217537
Outcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 48hours (AUC0-48) of Omadacycline After IV Infusion | Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion | Pharmacokinetic Evaluable Population include all participants who received study drug and have at least one evaluable pharmacokinetic parameter. | hours*nanograms per milliliter (h*ng/ml) | GEOMETRIC_MEAN |
| PRIMARY | AUC(0-48) of Omadacycline After Oral Administration | Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing | Pharmacokinetic Evaluable Population. Only those participants with data available at specified time points have been presented. | h*ng/ml | GEOMETRIC_MEAN |
| PRIMARY | AUC From Time 0 to the Last Quantifiable Concentration (AUClast) of Omadacycline After IV Infusion | Pre-dose (At least 15 minutes prior to IV infusion), and 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion | Pharmacokinetic Evaluable Population | h*ng/ml | GEOMETRIC_MEAN |
| PRIMARY | AUClast of Omadacycline After Oral Administration | Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing | Pharmacokinetic Evaluable Population | h*ng/ml | GEOMETRIC_MEAN |
| PRIMARY | AUC From Time 0 Extrapolated to Infinity (AUC0-inf) of Omadacycline After IV Infusion | Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion | Pharmacokinetic Evaluable Population | h*ng/ml | GEOMETRIC_MEAN |
| PRIMARY | AUC0-inf of Omadacycline After Oral Administration | Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing | Pharmacokinetic Evaluable Population. Only those participants with data available at specified time points have been presented. | h*ng/ml | GEOMETRIC_MEAN |
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of Omadacycline After IV Infusion | Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion | Pharmacokinetic Evaluable Population | nanograms/milliliter (ng/ml) | GEOMETRIC_MEAN |
| PRIMARY | Cmax of Omadacycline After Oral Administration | Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing | Pharmacokinetic Evaluable Population | ng/ml | GEOMETRIC_MEAN |
| PRIMARY | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Omadacycline After IV Infusion | Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion | Pharmacokinetic Evaluable Population | hours | MEDIAN |
| PRIMARY | Tmax of Omadacycline After Oral Administration | Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing | Pharmacokinetic Evaluable Population | hours | MEDIAN |
| PRIMARY | Elimination Half-life Associated With the Terminal Slope of the Semilogarithmic Concentration-time Curve (t1/2) of Omadacycline After IV Infusion | Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion | Pharmacokinetic Evaluable Population | hours | GEOMETRIC_MEAN |
| PRIMARY | t1/2 of Omadacycline After Oral Administration | Predose (At least 15 minutes prior to oral administration), 1, 2, 3, 8, 24 and 48 hours after dosing | Pharmacokinetic Evaluable Population. Only those participants with data available at specified time points have been presented. | hours | GEOMETRIC_MEAN |
| PRIMARY | Apparent Volume of Distribution During the Terminal Phase (Vz) of Omadacycline After IV Infusion | Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion | Pharmacokinetic Evaluable Population | liters | GEOMETRIC_MEAN |
| PRIMARY | Systemic Clearance (CL) of Omadacycline After IV Infusion | Predose (At least 15 minutes prior to IV infusion), 10 minutes, 0.5, 1, 2, 8, 24 and 48 hours after the end of IV infusion | Pharmacokinetic Evaluable Population | Liters per hour (L/h) | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs), by Relationship to the Study Drug. | Up to Day 7 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Reporting TEAE by Severity | Up to Day 7 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Reporting TEAE, Serious Adverse Events (SAEs) and AE Leading to Discontinuation of Study Drug | Up to Day 7 | Safety Population | participants | NUMBER |
| SECONDARY | Number of Participants With Change From Baseline in Hematology Parameters | Up to Day 2 | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Change From Baseline in Serum Chemistry Parameters | Up to Day 2 | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Change From Baseline in Vital Signs | Up to Day 2 | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05217537/outcomes