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| Name | Class |
|---|---|
| IQVIA RDS Inc. | INDUSTRY |
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The purpose of this study is to evaluate if TBD09 in combination with other active agents in adults with drug sensitive pulmonary tuberculosis has potential to be safe and effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | The combination of TBD09 (100 mg three times weekly, TIW), bedaquiline and pretomanid |
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| Group 2 | Experimental | The combination of TBD09 (100 mg QD), bedaquiline and pretomanid |
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| Group 3 | Experimental | The combination of TBD09 (300 mg QD), bedaquiline and pretomanid |
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| Group 4 | Experimental | The combination of TBD09 (500 mg QD), bedaquiline and pretomanid |
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| Group 5 | Active Comparator | The combination of linezolid (600 mg QD), bedaquiline and pretomanid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bedaquiline, pretomanid and TBD09 | Drug | Group 1 (30 participants): The combination of TBD09 (100 mg three times weekly, TIW), bedaquiline (200 mg daily, QD), and pretomanid (200 mg QD), 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Bactericidal Activity | Average daily change in MGIT sputum culture TTD from baseline to end-of-treatment (EOT) | From randomization through Day 28 (EOT) |
| Safety: SAEs | Proportion of participants with this event | Screening through Day 35 (EOS) |
| Safety: TEAEs | Proportion of participants with this event | Screening through Day 35 (EOS) |
| Safety: AESIs | Proportion of participants with this event | Screening through Day 35 (EOS) |
| Safety: AEs leading to treatment discontinuation | Proportion of participants with this event | Screening through Day 35 (EOS) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Hematologic Effect | Proportion of participants who meet each of the following binary classifications of platelets, absolute neutrophil count (ANC), total white blood cell count (WBC), absolute lymphocyte count (ALC), and hemoglobin:
|
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Inclusion Criteria:
Age 18-65 years at consent
Body weight 35-100 kg at screening
Written informed consent obtained
Newly diagnosed rifampicin-sensitive pulmonary TB
Chest X-ray consistent with TB (Investigator assessment)
Able to spontaneously produce sputum
Reproductive requirements met
Women of childbearing potential: 2 approved contraceptive methods or abstinence
Males: contraception or abstinence through 90 days post-dose
Exclusion Criteria:
Prior anti-TB treatment for the current TB episode within 60 days
Prior medication active against Mtb within 3 months
Evidence of extra-thoracic TB, per investigator judgement
Prior treatment completion for TB within 3 years
2 or more prior episodes of TB
Clinically significant history of or current medical condition posing safety risk
If HIV positive:
Meets any of the following laboratory values during screening:
Current or recent systemic immunosuppressive therapy, including corticosteroids
Significant drug or alcohol abuse affecting compliance or safety
Pregnant or breastfeeding, positive pregnancy test, or planning pregnancy shortly after treatment
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gates MRI | Contact | +1 857 702 2108 | clinical.trials@gatesmri.org | |
| Gates MRI | Contact | +1-866-789-5757 |
| Name | Affiliation | Role |
|---|---|---|
| Gates MRI | Gates Medical Research Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Enhancing Care Foundation at Wentworth Hospital | Recruiting | Durban | Bluff | 4052 | South Africa |
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Within 12 months of study completion date
Anonymized participant-level data may be shared with the external research in accordance with trial participant' written and executed informed consent and applicable local regulations. Qualified research may submit a request along with a research proposal to Gates MRI for review. A data sharing agreement must be in place before any clinical trial data are shared. Additional restrictions may apply due to contractual obligations or regulatory constraints.
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| Bedaquiline, pretomanid and TBD09 | Drug | Group 2 (30 participants): The combination of TBD09 (100 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days |
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| Bedaquiline, pretomanid and TBD09 | Drug | Group 3 (30 participants): The combination of TBD09 (300 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days |
|
| Bedaquiline, pretomanid and TBD09 | Drug | Group 4 (30 participants): The combination of TBD09 (500 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days |
|
| Bedaquiline, pretomanid and linezolid | Drug | Group 5 (30 participants): The combination of linezolid (600 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days |
|
| Randomization through Day 35 (EOS) |
| Safety: Visual Acuity Assessment | Proportion of participants with worsening of postbaseline visual acuity score of 2 lines or more in either eye using Snellen-type charts | Randomization through Day 35 (EOS) |
| Safety: Colour Vision Assessment | Proportion of participants with a new or worsening post-baseline color vision abnormality in either eye (by severity grade) using Ishihara plates | Randomization through Day 35 (EOS) |
| Safety: Brief Peripheral Neuropathy Screen (BPNS) score | Proportion of participants with a reported new or worsening post-baseline peripheral neuropathy symptom on BPNS in either lower extremity (overall and by severity grade) | Randomization through Day 35 (EOS) |
| Safety: Brief Peripheral Neuropathy Screen (BPNS) score | Proportion of participants with a new or worsening post-baseline peripheral neuropathy objective physical finding on BPNS in either lower extremity (overall and by severity grade) | Randomization through Day 35 (EOS) |
| Safety: Brief Peripheral Neuropathy Screen (BPNS) score | Proportion of participants with new or worsening post-baseline peripheral neuropathy as defined by new/worsening symptom and new/worsening objective physical finding on BPNS in the same lower extremity (overall and by severity grade). | Randomization through Day 35 (EOS) |
| Bactericidal activity | Proportion of participants with negative MGIT sputum cultures at D28 | Day 28 (EOT) |
| Maximum plasma concentration (Cmax) of TBD09 | Concentrations of TBD09 administered in an investigational combination regimen. | Day 1 and Day 28 |
| Time to maximum plasma concentration (Tmax) of TBD09 | Concentrations of TBD09 administered in an investigational combination regimen. | Day 1 and Day 28 |
| Area under the curve from 0 to 24 hours (AUC0-24) of plasma concentration of TBD09 | Concentrations of TBD09 administered in an investigational combination regimen. | Day 1 |
| Area under the curve from 0 to infinity (AUC0-inf) of plasma concentration of TBD09 | Concentrations of TBD09 administered in an investigational combination regimen. | Day 28 |
| Area under the curve over the dosing interval on day 28 (AUCtau) of plasma concentration of TBD09 | Concentrations of TBD09 administered in an investigational combination regimen. | Day 28 |
| Accumulation ratio (Area under the curve from 0 to the end of the dosing interval (AUCtau) / AUC0-24), Day 28 vs Day 1 of plasma concentration of TBD09 | Concentrations of TBD09 administered in an investigational combination regimen. | Day 1 and Day 28 |
| TASK Applied Science - Eden | Recruiting | George | Central | 6529 | South Africa |
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| Clinical Research and HIV Research Unit (CHRU) @ Helen Joseph Hospital | Recruiting | Johannesburg | Gauteng | 2092 | South Africa |
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| The Aurum Institute Tembisa | Not yet recruiting | Tembisa | Gauteng | 1736 | South Africa |
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| CHRU @ Isango Lethemba | Recruiting | Bethelsdorp | Gqeberha | 6003 | South Africa |
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| Madibeng Centre for Research | Recruiting | Brits | North West | 0250 | South Africa |
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| Setshaba Research Center | Recruiting | Pretoria | Soshangue | 0152 | South Africa |
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| ONE MRI | Recruiting | Cape Town | Western Cape | 7405 | South Africa |
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| TASK Applied Science - Brookylyn Chest Hospital | Recruiting | Cape Town | Western Cape | 7405 | South Africa |
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| BioMedical Research Institute - Stellenbosch University @ Tygerberg Hospital | Recruiting | Cape Town | Western Cape | 7505 | South Africa |
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| UCT Lung Institute (Pty) Ltd (Centre for TB Research Innovation) | Recruiting | Cape Town | Western Cape | 7700 | South Africa |
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| Desmond Tutu Health Foundation | Recruiting | Cape Town | Western Cape | 7750 | South Africa |
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| Synergy Biomedical Research Institute (SBRI) | Recruiting | East London | 5241 | South Africa |
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| ID | Term |
|---|---|
| C493870 | bedaquiline |
| C410767 | pretomanid |
| D000069349 | Linezolid |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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