Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Azithromycin- every other day for 3 weeks · 1 trial · 1 indication
Parameters from PK/PD modelling of the time course of concentrations and inhibition/induction of relevant ex vivo biomarkers (e.g., MDC, GM-CSF and IL-10 with varying levels of LPS stimulation) including the IC50 along with distribution parameters (e.g., kin and kout).
Maximum inhibition/induction of relevant ex vivo biomarkers (e.g., MDC, GM-CSF and IL-10) and timing of this maximum
| Arm | Type | Description |
|---|---|---|
| Part A - randomized, open-label parallel group | ACTIVE_COMPARATOR | Part A is a randomized, open-label parallel group study evaluating PK/PD of a single azithromycin dose of 250 or 1000 mg. Data from Part A will be used to assess the dose resulting in induction/inhibition of various ex vivo biomarkers relative to a 250 mg dose of azithromycin (the clinical dose used in treatment of neutrophil-induced inflammatory conditions). This information will guide the range of doses to be studied in a FTIH study of a new chemical entity. |
| Part B - repeat dose group | ACTIVE_COMPARATOR | Part B is a repeat dose study treating subjects with Azithromycin (250 mg every other day for 3 weeks), the dose approximates that used in the treatment of chronic neutrophil-related inflammatory conditions. This information will provide insight into whether the biomarker effects change over time on repeat dosing and any potential differences observed between single and repeat doses. |
| Name | Type | Description |
|---|---|---|
| Azithromycin - 250 mg | DRUG | Part A - A single azithromycin dose of 250 mg. |
| Azithromycin - 1000 mg | DRUG | Part A - A single azithromycin dose of 1000 mg. |
| Azithromycin - 250 mg every other day for 3 weeks | DRUG | Part B - Repeat dose study treating subjects with Azithromycin (250 mg every other day for 3 weeks), the dose approximates that used in the treatment of chronic neutrophil-related inflammatory conditions. |
Inclusion Criteria: * Male or female between 18 and 65 years of age inclusive * Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy * Child-bearing potential and agrees to use one of the contraception methods * Body weight ≥ 50 kg and body m...
This dosing regimen of azithromycin is being studied in autoimmune diseases, within the immunology therapeutic area. It is an investigational use, and the drug is a small molecule. The regimen refers to 250 mg of azithromycin taken every other day for 3 weeks.
GSK plc, which trades under the ticker GSK, is the developer of this azithromycin regimen for autoimmune diseases. The company sponsored the clinical work evaluating single and repeat dosing of azithromycin in this setting.
This azithromycin regimen is in Phase 1 development for autoimmune diseases. It is investigational and has not been approved for this use. The Phase 1 program has completed, with one trial conducted in the United Kingdom.
The regimen was evaluated in trial NCT01416350, titled A Single and Repeat Dose PK/PD Study to Characterise Biomarker Response in Healthy Subjects Treated With Azithromycin. The Phase 1 trial enrolled 20 healthy adult volunteers in the United Kingdom, was randomized and active controlled, and has completed.
Yes. Azithromycin 250 mg every other day for 3 weeks is an alternative name for the same azithromycin regimen. It describes the specific dose and schedule used in the Phase 1 autoimmune disease study, distinguishing it from other azithromycin dosing schedules.
The Phase 1 trial of azithromycin dosed every other day for 3 weeks enrolled 20 participants. It was a randomized, active controlled study in healthy volunteers aged 18 years and older, and it has completed. Participants of all sexes were eligible.