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NCT01416350
A Single and Repeat Dose PK/PD Study to Characterise Biomarker Response in Healthy Subjects Treated With Azithromycin
Phase 1 trial testing Azithromycin - 250 mg in Autoimmune Diseases in 20 participants. Completed in 12 May 2011.
12 May 2011
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 20 |
| Start date | 30 March 2011 |
| Primary completion | 12 May 2011 |
| Estimated completion | 12 May 2011 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Azithromycin - 250 mg
- Azithromycin - 1000 mg
- Azithromycin - 250 mg every other day for 3 weeks — full drug profile →
Conditions studied
- Autoimmune Diseases — all drugs for Autoimmune Diseases →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
Adults 18 to 65, any sex, with Autoimmune Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a two part protocol (Parts A and B) in healthy volunteers evaluating the pharmacokinetics/ pharmacodynamics (PK/PD) of azithromycin to investigate the usefulness of various biomarkers (e.g., Interleukin-10 (IL-10), Granulocyte macrophage colony-stimulating factor (GM-CSF), mature dendritic cell (MDC), with and without ex vivo lipopolysaccharide (LPS) stimulation) as markers of macrolide anti-inflammatory activity. 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 first time in humans (FTIH) study of a new chemical entity. 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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Population pharmacokinetics of azithromycin in whole blood, peripheral blood mononuclear cells, and polymorphonuclear cells in healthy adults.
Sampson MR, Dumitrescu TP, Brouwer KL, Schmith VD. · · 2014 · cited 18× · PMID 24599342 · DOI 10.1038/psp.2013.80
Verify or expand the search:
- PubMed search for NCT01416350
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01416350 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
- Last refreshed: 21 July 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01416350.
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