Comparison · NCT05981365-d3c19171
Part B: Period 1 vs Part B: Period 2: Part B: Number of Participants With Clinically Significant Abnormalities in Laboratory Tests
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Part B: Period 1 vs Part B: Period 2: Part B: Number of Participants With Clinically Significant Abnormalities in Laboratory Tests. Trial comparisons, record NCT05981365-d3c19171. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05981365-d3c19171
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0 | 0.176 | wilson | |
| Risk in group 2 | 0 | 0 | 0.176 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.176 | 0.176 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Part B: Period 1 | On Day 1 of Period 1, participants were administered a single oral dose of Treatment A (metformin 10 mg, furosemide 1 mg, and rosuvastatin 10 mg). Period 1 for Part B was of 4 days. | 0 | 18 | OG000 |
| Group 2 | Part B: Period 2 | In Period 2, from Day 1 to Day 3, participants were administered Treatment B (oral doses of voxelotor 1500 mg) orally for 3 days. On Day 4, participants were administered Treatment C (single oral doses of metformin 10 mg, furosemide 1 mg, and rosuvastatin 10 mg) immediately following voxelotor administration. On Day 5, participants were administered Treatment D (single oral dose of voxelotor 1500 mg). Period 2 for Part B was of 7 days. There was a washout period of 7 to 14 days in between Period 1 and 2. Participants had a follow-up visit on Day 18. | 0 | 18 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- Part B: Number of Participants With Clinically Significant Abnormalities in Laboratory Tests
- Description
The following laboratory parameters were assessed: hematology: hematocrit, hemoglobin, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, red blood cell count, neutrophils, monocytes, lymphocytes, basophils and eosinophils. coagulation: prothrombin time, partial thromboplastin time, international normalized ratio. Serum Chemistry: albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, creatinine, blood urea nitrogen, lactate dehydrogenase. Urinalysis: ketones, pH, protein, blood glucose, bilirubin, chloride, bicarbonate, phosphorous, potassium was assessed. Clinical significance of laboratory abnormalities was determined by investigator.
- Time frame
- From start of study drug on Day 1 up to Day 18 (for a maximum of 20 days)
- Population
SAS included all participants who received any amount of study drug (voxelotor or cocktail drugs \[probe substrates\]). As prespecified in the statistical analysis plan, safety data is reported period-wise.
Source ClinicalTrials.gov
Trial
- Title
- Voxelotor CYP and Transporter Cocktail Interaction Study
- NCT number
- NCT05981365
- Phases
- PHASE1
- Conditions
- Sickle Cell Disease
- Interventions
- Voxelotor, Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, Metformin, Furosemide, Rosuvastatin
- Lead sponsor
- Pfizer
- Results first posted
- 2024-11-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05981365?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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