An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
NCT07923383, Phase 1, Not yet recruiting, Sanofi
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates | ClinicalTrials.gov |
| NCT number | NCT07923383 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 25 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Sanofi | ClinicalTrials.gov |
| Conditions | Ulcerative Colitis, Crohn's Disease | ClinicalTrials.gov |
| Interventions | Duvakitug | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | AUC for CYP isoform specific substrates midazolam, omeprazole, warfarin, caffeine, and metoprolol | At Treatment Period 1 (CYP substrates alone, Day 1) and after 12 weeks of duvakitug (Treatment Period 2, Day 85) | AUC: Area under the plasma concentration versus time curve extrapolated to infinity | ClinicalTrials.gov |
| Primary | AUClast for CYP isoform specific substrates midazolam, omeprazole, warfarin, caffeine, and metoprolol | At Treatment Period 1 (CYP substrates alone, Day 1) and after 12 weeks of duvakitug (Treatment Period 2, Day 85) | AUClast: Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast | ClinicalTrials.gov |
| Secondary | Duvakitug serum concentrations: Ctrough | At Treatment Period 2, from Day 1 to Day 85 | Ctrough: Serum concentration observed just before treatment administration during multiple dosing | ClinicalTrials.gov |
| Secondary | tmax of CYP substrates alone and after duvakitug administration | At Treatment Period 1 (CYP substrates alone, Day 1) and after 12 weeks of duvakitug (Treatment Period 2, Day 85) | tmax: Time to reach Cmax | ClinicalTrials.gov |
| Secondary | t1/2 of CYP substrates alone and after duvakitug administration | At Treatment Period 1 (CYP substrates alone, Day 1) and after 12 weeks of duvakitug (Treatment Period 2, Day 85) | Terminal half-life associated with the terminal slope (λz) where λz is the slope of the regression line of the terminal phase of the plasma concentration versus time curve, in semi logarithmic scale. Half-life is calculated by taking the regression of at least 3 points. | ClinicalTrials.gov |
| Secondary | tlast of CYP substrates alone and after duvakitug administration | At Treatment Period 1 (CYP substrates alone, Day 1) and after 12 weeks of duvakitug (Treatment Period 2, Day 85) | tlast: Time corresponding to the last concentration above the limit of quantification, Clast | ClinicalTrials.gov |
| Secondary | Cmax of CYP substrates alone and after duvakitug administration | At Treatment Period 1 (CYP substrates alone, Day 1) and after 12 weeks of duvakitug (Treatment Period 2, Day 85) | Cmax: Maximum plasma concentration observed | ClinicalTrials.gov |
| Secondary | Number of participants with anti-drug antibodies against duvakitug | At Treatment Period 2, from Day 1 to Day 85 | ClinicalTrials.gov | |
| Secondary | Number of participants with TEAEs, TESAEs, TEAESIs, and TEAEs leading to permanent study intervention discontinuation | From Treatment Period 1, Day 1 until the End of Study visit (approximately 130 days) | TEAE: treatment-emergent adverse event, TESAE: treatment-emergent serious adverse event, TEAESI: treatment-emergent adverse event of special interest | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)