AsthmaPhase 1/2NCT02041221

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPARC1316

A Phase 1/2 study testing SPARC1316 Dose 1, SPARC1316 Dose 2 and SPARC1316 Dose 3 in people with Asthma, run by Sun Pharma Advanced Research Company Limited at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Asthma
What is being tested?: SPARC1316 Dose 1, SPARC1316 Dose 2 and SPARC1316 Dose 3
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: 1 siteUnited Kingdom
Study dates: Jan 2014to Nov 2014
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects willing to provide informed consent
Male or female subjects aged 18 to 65 years inclusive
Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive
Non-smokers or ex-smokers

Who cannot join

Subjects with a supine systolic blood pressure ≥160 mmHg and/or a supine diastolic blood pressure ≥100 mmHg
Subjects who have a significant infection or known inflammatory process on screening or admission.
Subjects who are unlikely to co-operate with the requirements of the study.
Positive serology for infectious disease (hepatitisB or C , HIV) at screening

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

SPARC study site
London, London

Other trials in United Kingdom

About this study

Conditions: Asthma
Being tested: SPARC1316 Dose 1, Placebo, SPARC1316 Dose 2, SPARC1316 Dose 3, SPARC1316 Dose 4
Keywords: pharmacokinetics, pharmacodynamics, asthma
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SPARC1316 Dose 1Drug
The subjects will receive SPARC1316.
PlaceboDrug
Also called The subjects will receive a matching placebo by oral inhalation.
SPARC1316 Dose 2Drug
SPARC1316 Dose 3Drug
SPARC1316 Dose 4Drug
SPARC1316 Dose 5Drug

Study groups in NCT02041221
Study group	Role	What they receive
SPARC1316 Dose 1	Experimental	Subjects will be administered with SPARC1316 dose 1 Receives: Drug: SPARC1316 Dose 1
Placebo	Placebo comparator	The subjects will receive placebo. Receives: Drug: Placebo
SPARC1316 Dose 2	Experimental	Subjects will be administered with SPARC1316 dose 2 Receives: Drug: SPARC1316 Dose 2
SPARC1316 Dose 3	Experimental	Subjects will be administered with SPARC1316 dose 3 Receives: Drug: SPARC1316 Dose 3
SPARC1316 Dose 4	Experimental	Subjects will be administered with SPARC1316 dose 4 Receives: Drug: SPARC1316 Dose 4
SPARC1316 Dose 5	Experimental	Subjects will be administered with SPARC1316 dose 5 Receives: Drug: SPARC1316 Dose 5

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Adverse Events
The no of adverse events will be assessed to evaluate the safety and tolerability of compound SO597 in healthy male subjects and asthma patients
Measured: Two (2) Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Nov 2014

First posted20 Jan 2014 (estimated)
Study startJan 2014
Primary completionNov 2014
Study completionNov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02041221
Sponsor's protocol ID: SPARC_Ltd_ CLR_13_16
Status last verified: Apr 2016
First submitted: 14 Jan 2014
Last updated: 23 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
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RecruitingPhase 2
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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPARC1316
ClinicalTrials.gov ID: NCT02041221
Acronym / sponsor ID: SPARC_Ltd_ CLR_13_16
Conditions: Asthma
Keywords: pharmacokinetics, pharmacodynamics, asthma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
Study start: Jan 2014
Primary completion: Nov 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 20 Jan 2014 (estimated)
Results: Posted 31 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
SPARC1316 Dose 1	Experimental	Drug: SPARC1316 Dose 1Subjects will be administered with SPARC1316 dose 1
Placebo	Placebo comparator	Drug: PlaceboThe subjects will receive placebo.
SPARC1316 Dose 2	Experimental	Drug: SPARC1316 Dose 2Subjects will be administered with SPARC1316 dose 2
SPARC1316 Dose 3	Experimental	Drug: SPARC1316 Dose 3Subjects will be administered with SPARC1316 dose 3
SPARC1316 Dose 4	Experimental	Drug: SPARC1316 Dose 4Subjects will be administered with SPARC1316 dose 4
SPARC1316 Dose 5	Experimental	Drug: SPARC1316 Dose 5Subjects will be administered with SPARC1316 dose 5

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subjects willing to provide informed consent
Male or female subjects aged 18 to 65 years inclusive
Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive
Non-smokers or ex-smokers

Key exclusion criteria (4 listed)

Subjects with a supine systolic blood pressure ≥160 mmHg and/or a supine diastolic blood pressure ≥100 mmHg
Subjects who have a significant infection or known inflammatory process on screening or admission.
Subjects who are unlikely to co-operate with the requirements of the study.
Positive serology for infectious disease (hepatitisB or C , HIV) at screening

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SPARC1316 Dose 1The subjects will receive SPARC1316.	Drug	SPARC1316 Dose 1
PlaceboAlso: The subjects will receive a matching placebo by oral inhalation.	Drug	Placebo
SPARC1316 Dose 2	Drug	SPARC1316 Dose 2
SPARC1316 Dose 3	Drug	SPARC1316 Dose 3
SPARC1316 Dose 4	Drug	SPARC1316 Dose 4
SPARC1316 Dose 5	Drug	SPARC1316 Dose 5

Primary outcome

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

Results and safety

Results posted to the registry on 31 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
S0597 Dose 1	6	6
S0597 Dose 2	6	6
S0597 Dose 3	6	6
S0597 Dose 4	6	6
S0597 Dose 5	6	6
Placebo	10	10

Primary outcome: Number of Subjects With Adverse Events

Time frame: Two (2) Weeks. Number. Unit: participants

Measure	S0597 Dose 1 n = 6	S0597 Dose 2 n = 6	S0597 Dose 3 n = 6	S0597 Dose 4 n = 6	S0597 Dose 5 n = 6	Placebo n = 10
Value	0	0	0	0	1	2

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
S0597 Dose 1	0 of 6 (0%)	0 of 6 (0%)	Not reported
S0597 Dose 2	0 of 6 (0%)	0 of 6 (0%)	Not reported
S0597 Dose 3	0 of 6 (0%)	0 of 6 (0%)	Not reported
S0597 Dose 4	0 of 6 (0%)	0 of 6 (0%)	Not reported
S0597 Dose 5	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
Placebo	0 of 10 (0%)	2 of 10 (20%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SPARC1316 Dose 1, SPARC1316 Dose 2 and SPARC1316 Dose 3 in people with Asthma, run by Sun Pharma Advanced Research Company Limited at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Adverse Events (time frame: Two (2) Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02041221.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2016.