Trial · NCT07883226
A Phase 1 Multiple Dose Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, Drug-Drug Interactions, and Pharmacokinetics of TBD11
NCT07883226, Phase 1, Recruiting, Gates Medical Research Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 1 Multiple Dose Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, Drug-Drug Interactions, and Pharmacokinetics of TBD11. Trials, record NCT07883226. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07883226
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 1 Multiple Dose Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, Drug-Drug Interactions, and Pharmacokinetics of TBD11
- NCT number
- NCT07883226
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 66 participants, estimated
- Lead sponsor
- Gates Medical Research Institute
- Conditions
- Healthy Adult Participants
- Interventions
- TBD11 (300 mg), Placebo, Itraconazole (200 mg), Rifampicin 600mg, TBD11 (50 mg), TBD11 (up to 300 mg)
- First posted
- 2026-10-20
- Last updated
- 2026-10-22
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events | Cohort 1: Day 1 through Day 19. Cohort 2 Arm A: Period 1, Day 1 through Day 8; Period 2, Day -4 through Day 16. Cohort 2 Arm B: Period 1, Day 1 through Day 8; Period 2, Day -10 through Day 8. Cohort 3: Day 1 through Day 92. | Number of participants with one or more treatment-emergent adverse events, summarized overall and by severity, Investigator-assessed relationship to trial intervention, System Organ Class, and Preferred Term. |
| Primary | Number of Participants With Serious Adverse Events | Cohort 1: Day 1 through Day 19. Cohort 2 Arm A: Period 1, Day 1 through Day 8; Period 2, Day -4 through Day 16. Cohort 2 Arm B: Period 1, Day 1 through Day 8; Period 2, Day -10 through Day 8. Cohort 3: Day 1 through Day 92. | Number of participants with one or more serious adverse events, summarized overall and by severity, Investigator-assessed relationship to trial intervention, System Organ Class, and Preferred Term. |
| Primary | Number of Participants With Adverse Events Leading to Trial Intervention Interruption | Cohort 1: Day 1 through Day 19. Cohort 2 Arm A: Period 1, Day 1 through Day 8; Period 2, Day -4 through Day 16. Cohort 2 Arm B: Period 1, Day 1 through Day 8; Period 2, Day -10 through Day 8. Cohort 3: Day 1 through Day 92. | Number of participants with one or more adverse events resulting in temporary interruption of trial intervention, summarized overall and by severity, Investigator-assessed relationship to trial intervention, System Organ Class, and Preferred Term. |
| Primary | Number of Participants With Adverse Events Leading to Trial Intervention Discontinuation | Cohort 1: Day 1 through Day 19. Cohort 2 Arm A: Period 1, Day 1 through Day 8; Period 2, Day -4 through Day 16. Cohort 2 Arm B: Period 1, Day 1 through Day 8; Period 2, Day -10 through Day 8. Cohort 3: Day 1 through Day 92. | Number of participants with one or more adverse events resulting in permanent discontinuation of trial intervention, summarized overall and by severity, Investigator-assessed relationship to trial intervention, System Organ Class, and Preferred Term. |
| Primary | Number of Participants With Treatment-Emergent Clinical Chemistry Abnormalities | Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92. | Number of participants with treatment-emergent clinical chemistry abnormalities, summarized by visit, worst post-baseline grade, and grade shift from baseline using the protocol-specified toxicity grading criteria. |
| Primary | Number of Participants With Treatment-Emergent Hematology Abnormalities | Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92. | Number of participants with treatment-emergent hematology abnormalities, summarized by visit, worst post-baseline grade, and grade shift from baseline using the protocol-specified toxicity grading criteria. |
| Primary | Number of Participants With Treatment-Emergent Coagulation Abnormalities | Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92. | Number of participants with treatment-emergent coagulation abnormalities, summarized by visit, worst post-baseline grade, and grade shift from baseline using the protocol-specified toxicity grading criteria. |
| Primary | Number of Participants With Treatment-Emergent Urinalysis Abnormalities | Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92. | Number of participants with treatment-emergent urinalysis abnormalities, summarized by visit, worst post-baseline grade, and grade shift from baseline using the protocol-specified toxicity grading criteria. |
| Primary | Number of Participants With Treatment-Emergent Lipid Profile Abnormalities | Baseline and scheduled post-baseline assessments from Day 1 through Day 92 for Cohort 3. | Number of Cohort 3 participants with treatment-emergent lipid profile abnormalities, summarized by visit, worst post-baseline grade, and grade shift from baseline. |
| Primary | Change From Baseline in Systolic Blood Pressure | Cohort 1, Day 1 through Day 19; Cohort 2 Arm A, Period 1 Day 1 through Day 8 and Period 2 Day -4 through Day 16; Cohort 2 Arm B, Period 1 Day 1 through Day 8 and Period 2 Day -10 through Day 8; Cohort 3, Day 1 through Day 92. | Change from baseline in systolic blood pressure, measured in millimeters of mercury (mmHg). |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07883226
GET https://conductscience.org/api/trials/v1/NCT07883226/registered?page=2