Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2026-01-02 @ 4:10 AM
Study NCT ID:
NCT03959566
Status:
COMPLETED
Last Update Posted:
2023-05-01
First Post:
2019-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PanACEA Sutezolid Dose-finding and Combination Evaluation
Sponsor:
Michael Hoelscher
Organization:
Study Overview
Official Title:
A Phase IIB, Open-Label, Randomized Controlled Dose Ranging Multi-Center Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Exposure-Response Relationship of Different Doses of Sutezolid in Combination With Bedaquiline, Delamanid and Moxifloxacin in Adult Subjects With Newly Diagnosed, Uncomplicated, Smear-Positive, Drug-sensitive Pulmonary Tuberculosis
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUDOCU
Brief Summary:
This study is an open-label, randomized, controlled, multi-center Phase IIB dose-finding trial to evaluate the safety, tolerability, pharmacokinetics and exposure-response-relationship of different doses of sutezolid (STZ) in combination with bedaquiline, delamanid and moxifloxacin in adults with newly diagnosed, uncomplicated, smear positive and drug sensitive pulmonary tuberculosis. Participants will be randomized to one of five arms containing bedaquiline, delamanid and moxifloxacin with different doses of STZ (0mg, 600mg once daily (OD), 1200mg OD, 600 mg twice daily (BD), 800 mg BD). Study treatment duration will be three months, followed by a follow-up period of 2 weeks.
The primary objective is to identify the optimal dose of sutezolid to be used in subsequent studies that provides the best efficacy at acceptable safety of the drug by describing the safety, tolerability and exposure toxicity relationship of sutezolid (and its main metabolite) given over three months, in combination with standard-dose bedaquiline, delamanid and moxifloxacin, compared to standard-dose bedaquiline, delamanid and moxifloxacin alone.
The primary objective is to identify the optimal dose of sutezolid to be used in subsequent studies that provides the best efficacy at acceptable safety of the drug by describing the safety, tolerability and exposure toxicity relationship of sutezolid (and its main metabolite) given over three months, in combination with standard-dose bedaquiline, delamanid and moxifloxacin, compared to standard-dose bedaquiline, delamanid and moxifloxacin alone.
Detailed Description:
This open-label Phase IIB dose-finding, randomized, controlled study with a duration of three months of experimental therapy in adult patients with newly diagnosed, smear positive, uncomplicated, drug sensitive pulmonary tuberculosis (TB) will be carried out to evaluate the safety, efficacy, tolerability, pharmacokinetics and exposure/response-relationship of different doses of sutezolid in combination with bedaquiline, delamanid and moxifloxacin (BDM).
Participants will be randomized to one of five arms containing bedaquiline, delamanid and moxifloxacin with different doses of STZ (0mg, 600mg OD, 1200mg OD, 600 mg BD, 800 mg BD). Study treatment duration will be three month, followed by a follow-up period of 2 weeks.
A total of 75 male or female subjects, aged between 18 and 65 years with newly diagnosed, drug sensitive, uncomplicated, smear-positive, pulmonary TB will be included and randomized to one of five arms containing BDM with different doses of STZ:
* Arm 1 (U0): Bedaquiline, delamanid, moxifloxacin
* Arm 2 (U600): Bedaquiline, delamanid, moxifloxacin, sutezolid 600 mg OD
* Arm 3 (U1200): Bedaquiline, delamanid, moxifloxacin, sutezolid 1200 mg OD
* Arm 4 (U600BD): Bedaquiline, delamanid, moxifloxacin, sutezolid 600 mg BD
* Arm 5 (U800BD): Bedaquiline, delamanid, moxifloxacin, sutezolid 800 mg BD
A sub-study will assess CYP P450 3A4 enzyme induction potential using the probe drug midazolam, given to participants in arm 5.
Using PK data and data from primary efficacy and safety objectives, we will develop an exposure-response and a population PK-model for sutezolid and its main metabolite to support the main objective, selection of a dose for subsequent studies.
Participants will be randomized to one of five arms containing bedaquiline, delamanid and moxifloxacin with different doses of STZ (0mg, 600mg OD, 1200mg OD, 600 mg BD, 800 mg BD). Study treatment duration will be three month, followed by a follow-up period of 2 weeks.
A total of 75 male or female subjects, aged between 18 and 65 years with newly diagnosed, drug sensitive, uncomplicated, smear-positive, pulmonary TB will be included and randomized to one of five arms containing BDM with different doses of STZ:
* Arm 1 (U0): Bedaquiline, delamanid, moxifloxacin
* Arm 2 (U600): Bedaquiline, delamanid, moxifloxacin, sutezolid 600 mg OD
* Arm 3 (U1200): Bedaquiline, delamanid, moxifloxacin, sutezolid 1200 mg OD
* Arm 4 (U600BD): Bedaquiline, delamanid, moxifloxacin, sutezolid 600 mg BD
* Arm 5 (U800BD): Bedaquiline, delamanid, moxifloxacin, sutezolid 800 mg BD
A sub-study will assess CYP P450 3A4 enzyme induction potential using the probe drug midazolam, given to participants in arm 5.
Using PK data and data from primary efficacy and safety objectives, we will develop an exposure-response and a population PK-model for sutezolid and its main metabolite to support the main objective, selection of a dose for subsequent studies.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: