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NCT02041221
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPARC1316
Phase 1/Phase 2 trial testing SPARC1316 Dose 1 in Asthma in 64 participants. Completed in 1 November 2014.
1 November 2014
Quick facts
| Lead sponsor | Sun Pharma Advanced Research Company Limited |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 64 |
| Start date | 1 January 2014 |
| Primary completion | 1 November 2014 |
| Estimated completion | 1 November 2014 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- SPARC1316 Dose 1 — full drug profile →
- Placebo
- SPARC1316 Dose 2
- SPARC1316 Dose 3
- SPARC1316 Dose 4
- SPARC1316 Dose 5
Conditions studied
- Asthma — all drugs for Asthma →
Sponsor
Sun Pharma Advanced Research Company Limited — full company profile →
Who can join
Adults 18 to 65, any sex, with Asthma. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of Subjects With Adverse Events
Time frame: Two (2) Weeks
The no of adverse events will be assessed to evaluate the safety and tolerability of compound SO597 in healthy male subjects and asthma patients
Sponsor's own description
Sun Pharma Advanced Research company Limited has developed a dry powder inhaler of compound SPARC1316 for oral inhalation. This clinical study is a Phase I/IIa study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of S0597 administered by oral inhalation to healthy volunteers and asthma patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02041221
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Sun Pharma Advanced Research Company Limited trials
Trials by the same sponsor.
- NCT04942054 — A Study in Patients With Advanced Breast Cancer · Phase 1 · terminated
- NCT04332549 — To Assess the Bioavailability and Safety of Paclitaxel Injection Concentrate for Suspension in Subjects With Locally Rec · Phase 1 · withdrawn
- NCT04242953 — Study to Determine Safety, Tolerability and Pharmacokinetics, of SCO-120 in Healthy Male and Post-menopausal Female Subj · Phase 1 · completed
- NCT03655236 — PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase · Phase 2 · terminated
- NCT02597465 — A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507 · Phase 3 · withdrawn
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 NCT02041221 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sun Pharma Advanced Research Company Limited
- Last refreshed: 21 April 2016
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/NCT02041221.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing