Trial · NCT02850406
Outcomes54
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 54
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: Maximum Concentration (Cmax) of Voxelotor in Whole Blood | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | Pharmacokinetic (PK) population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. | Nanogram per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Part A: Area Under the Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Voxelotor in Whole Blood | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. | Hours*nanogram per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Part A: Area Under the Concentration-Time Curve (AUC) From Time 0 Extrapolated to Infinity (AUC0-inf) of Voxelotor in Whole Blood | pre-dose, 2, 8, 24, 48, 96,168 and 336 hours post-dose | PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Hours*nanogram per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Part B: Change From Baseline to Week 24 in Hemoglobin Level | Baseline, Week 24 | Efficacy-Evaluable Population comprised of all participants who received any amount of study drug. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Gram per deciliter | MEAN |
| PRIMARY | Part C: Change From Baseline to Week 48 in Cerebral Blood Flow | Baseline, Week 48 | Efficacy-Evaluable Population comprised of all participants who received any amount of study drug. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Centimeter per second | MEAN |
| PRIMARY | Part D: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From start of study treatment up to 28 days after study treatment discontinuation (Up to 52 weeks) | Safety population comprised of all participants who received any amount of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A: Maximum Concentration (Cmax) of Voxelotor in Plasma | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Nanogram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Part A: Maximum Concentration (Cmax) of Voxelotor in Red Blood Cells (RBC) | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Nanogram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Part A: Area Under the Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Voxelotor in Plasma | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Hours*nanogram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Part A: Area Under the Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Voxelotor in RBC | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Hours*nanogram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Part A: Area Under the Concentration-Time Curve (AUC) From Time 0 Extrapolated to Infinity (AUC0-inf) of Voxelotor in Plasma | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Hours*nanogram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Part A: Area Under the Concentration-Time Curve (AUC) From Time 0 Extrapolated to Infinity (AUC0-inf) of Voxelotor in RBC | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Hours*nanogram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Part A: Time at Which Cmax Was Observed (Tmax) for Voxelotor in Whole Blood | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. | Hours | MEDIAN |
| SECONDARY | Part A: Time at Which Cmax Was Observed (Tmax) for Voxelotor in Plasma | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Hours | MEDIAN |
| SECONDARY | Part A: Time at Which Cmax Was Observed (Tmax) for Voxelotor in RBC | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Hours | MEDIAN |
| SECONDARY | Part A: Terminal Elimination Half-Life (T1/2) for Voxelotor in Whole Blood | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Hours | GEOMETRIC_MEAN |
| SECONDARY | Part A: Terminal Elimination Half-Life (T1/2) for Voxelotor in Plasma | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Hours | GEOMETRIC_MEAN |
| SECONDARY | Part A: Terminal Elimination Half-Life (T1/2) for Voxelotor in RBC | pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose | PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Hours | GEOMETRIC_MEAN |
| SECONDARY | Part A: Percentage Hemoglobin (Hb) Occupancy | 15 days | Data was not collected as the model for Hb occupancy within RBCs was not developed for single dose administration (Part A). The model used to determine % Hb Occupancy was constructed via populational PK modelling and required data from multiple dose administration, thus cannot be applied to estimate the % Hb Occupancy for single doses. | ||
| SECONDARY | Part B: Percentage of Days With SCD Symptom Exacerbation During the First 24 Weeks of Treatment | From Day 1 up to 24 weeks | The variable represents a derivation from a new instrument developed by the sponsor specifically for this clinical program. Due to challenges in the validation of Percentage of Days With SCD Symptom Exacerbation from the instrument, specifically with the impact of missing data, the construct of this variable was not possible. A decision not to analyze this variable was documented in the statistical analysis plan. |
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.
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