Healthy VolunteersPhase 1/2NCT02958982

Safety, Tolerability and Pharmacokinetics of Oral Doses of RP3128 of Rhizen Pharmaceuticals

A Phase 1/2 study testing RP3128 in people with Healthy Volunteers and Asthma, run by Rhizen Pharmaceuticals SA at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

RP3128 is a calcium release activated calcium (CRAC) channel modulator. The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending dose(s) of RP3128 in healthy volunteers and to evaluate the effect on late phase asthmatic response to allergen challenge in… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers, Asthma
What is being tested?: RP3128
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 57 participants
Where: 1 siteCanada
Study dates: 3 Nov 2016to Feb 2018
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

Male and non-childbearing female subjects (SAD/MAD) and male and non-childbearing female patients with mild asthma;
Healthy subjects as determined by past medical history, vitals, physical examination and 12-lead ECG, clinical laboratory tests.
Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive, weight ≥50 kg;
Non-smokers or ex-smokers
Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the subject; able to comply with protocol requirements and or study procedure;
Negative screen for drugs of abuse and alcohol at screening and on admission.

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Male subjects should agree not to donate sperm for 3 months post dose; and
Female partners (of child bearing potential) of male subjects should use 2 methods of highly effective contraception for 3 months post last
Additionally for POC
Pre- bronchodilator Forced expiratory volume in 1 sec( FEV1) of > 70% (adjusted for age, sex and race)
Steroid naïve subjects with history of mild asthma that satisfy the Global Initiative for Asthma (GINA) definition of asthma, but otherwise healthy.

Who cannot join

Subjects with evidence or history of clinically significant medical history.
History of tuberculosis (TB) and/or a positive Tuberculin Skin Test and/or QuantiFeron- TB®-Gold test.
Use of any immunotherapy within 3 months prior to screening.
History of serious adverse reaction, severe hypersensitivity or allergy to any drug/drug substance (except house dust mite, pollen allergens or cat dander allergy in asthmatics) or in any other circumstance (e.g. anaphylaxis);
Abnormal liver function
Positive screen on hepatitis-B surface antigen (HBsAg), antibodies to the hepatitis C (HCV) or antibodies to the human immunodeficiency virus (HIV) 1,2;

Trial locations and contacts

1 site in 1 country.

Canada1 site

Inflamax Research Inc.
Mississauga, Ontario, L4W 1A4

Other trials in Canada

About this study

Official title: A Phase I/IIa, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety, and Pharmacokinetics of Single and Multiple Ascending Dose of RP3128 in HV and Effect on LAR to Allergen Challenge in Mild Asthmatics

Read the detailed description

The study consists of three parts; Part 1: single ascending dose (SAD), Part 2: multiple ascending dose (MAD) in healthy volunteers and Part 3: proof of concept (POC) study in mild asthmatics. There will be 5 cohorts in SAD and 3 cohorts in MAD, the doses used in the MAD will be based on emerging safety, tolerability and pharmacokinetics (PK) from Part 1 (SAD). POC is a randomized, placebo- controlled, double blind, two period cross-over, proof of concept study in male and female of non child bearing potential with history of mild asthma. the highest identified dose of RP3128 in Part 2 (MAD) will be considered for POC

Conditions: Healthy Volunteers, Asthma
Being tested: RP3128, Placebo
Keywords: RP3128, Phase 1, Healthy volunteers
Medical subject headings: Asthma

What participants receive

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

RP3128Drug
Also called CRAC channel modulator
Participants will receive single oral dose of RP3128 in SAD, multiple dose in MAD AND POC
PlaceboDrug
Participants will receive single oral dose of RP3128 in SAD, multiple dose in MAD AND POC

Study groups in NCT02958982
Study group	Role	What they receive
RP3128	Experimental	RP3128, A CRAC channel modulator Receives: Drug: RP3128
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

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

Number of Participants With Adverse Events
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Measured: Baseline through 2 weeks

Secondary outcomes (6)

Peak Plasma Concentration (Cmax)
Cmax after administration of RP3128/ placebo in part 1 and part 2
Measured: Pre-dose through 48 hours post dose
Measurement of Cytokines
Levels of cytokines following LPS (lipopolysaccharide) or CD3/CD28 stimulation.
Measured: Predose and Day 7 in Part 2
Fractional Exhaled Nitric Oxide (FeNo)
Change in FeNo after administration of RP3128/ placebo in part 3
Measured: Prechallenge to 3, 8 and 24 hours post challenge in Part 3
Area Under Effective Concentration (AUEC)
AUEC0-3h, AUEC3-8h after administration of RP3128/ placebo in part 3
Measured: 0 to 3 hours and 3 to 8 hours post allergen challenge in Part 3
Cell Count
Absolute and % counts of sputum eosinophils and neutrophils
Measured: 8 and 24 hours post allergen challenge in Part 3
Area Under the Plasma-Concentration
AUC0-t after administration of RP3128/ placebo in part 1 and part 2
Measured: Pre-dose through 48 hours post dose

Timeline

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

3 Nov 2016Feb 2018

First posted8 Nov 2016 (estimated)
Study start3 Nov 2016
Primary completionFeb 2018
Study completionFeb 2018

Why it stopped: Significant recruitment delay in POC part

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteersStudies 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: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02958982
Sponsor's protocol ID: RP3128-1601
Status last verified: Sep 2019
First submitted: 31 Oct 2016
Last updated: 4 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Barde PJ, Viswanadha S, Veeraraghavan S, Vakkalanka SV, Nair A. A first-in-human study to evaluate the safety, tolerability and pharmacokinetics of RP3128, an oral calcium release-activated calcium (CRAC) channel modulator in healthy volunteers. J Clin Pharm Ther. 2021 Jun;46(3):677-687. doi: 10.1111/jcpt.13322. Epub 2020 Dec 11.
PubMed 33314326

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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Study at a glance

From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/IIa, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety, and Pharmacokinetics of Single and Multiple Ascending Dose of RP3128 in HV and Effect on LAR to Allergen Challenge in Mild Asthmatics
ClinicalTrials.gov ID: NCT02958982
Acronym / sponsor ID: RP3128-1601
Conditions: Healthy Volunteers, Asthma
Keywords: RP3128, Phase 1, Healthy volunteers
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Significant recruitment delay in POC part
Enrolment: 57 participants (actual)
Lead sponsor: Rhizen Pharmaceuticals SAIndustry (pharma, biotech, devices)
Study start: 3 Nov 2016 (actual)
Primary completion: Feb 2018 (actual)
Study completion: Feb 2018 (actual)
First posted: 8 Nov 2016 (estimated)
Results: Posted 4 Oct 2019

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
RP3128	Experimental	Drug: RP3128RP3128, A CRAC channel modulator
Placebo	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

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

Key inclusion criteria (11 listed)

Male and non-childbearing female subjects (SAD/MAD) and male and non-childbearing female patients with mild asthma;
Healthy subjects as determined by past medical history, vitals, physical examination and 12-lead ECG, clinical laboratory tests.
Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive, weight ≥50 kg;
Non-smokers or ex-smokers
Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the subject; able to comply with protocol requirements and or study procedure;

Key exclusion criteria (6 listed)

Subjects with evidence or history of clinically significant medical history.
History of tuberculosis (TB) and/or a positive Tuberculin Skin Test and/or QuantiFeron- TB®-Gold test.
Use of any immunotherapy within 3 months prior to screening.
History of serious adverse reaction, severe hypersensitivity or allergy to any drug/drug substance (except house dust mite, pollen allergens or cat dander allergy in asthmatics) or in any other circumstance (e.g. anaphylaxis);
Abnormal liver function

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
RP3128Also: CRAC channel modulatorParticipants will receive single oral dose of RP3128 in SAD, multiple dose in MAD AND POC	Drug	RP3128
PlaceboParticipants will receive single oral dose of RP3128 in SAD, multiple dose in MAD AND POC	Drug	Placebo

Primary outcome

Number of Participants With Adverse Events
Time frame: Baseline through 2 weeks
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

6 secondary outcomes

Peak Plasma Concentration (Cmax)
Time frame: Pre-dose through 48 hours post dose
Measurement of Cytokines
Time frame: Predose and Day 7 in Part 2
Fractional Exhaled Nitric Oxide (FeNo)
Time frame: Prechallenge to 3, 8 and 24 hours post challenge in Part 3
Area Under Effective Concentration (AUEC)
Time frame: 0 to 3 hours and 3 to 8 hours post allergen challenge in Part 3
Cell Count
Time frame: 8 and 24 hours post allergen challenge in Part 3
Area Under the Plasma-Concentration
Time frame: Pre-dose through 48 hours post dose

Results and safety

Results posted to the registry on 4 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pooled Placebo (SAD)	1	1
RP3128_25 mg_SAD	3	3
RP3128_50 mg_SAD	0	0
RP3128_100 mg_SAD	0	0
RP3128_200 mg_SAD	0	0
RP3128_400 mg_SAD	0	0
Pooled Placebo (MAD)	0	0
RP3128_25 mg_MAD	0	0
RP3128_100 mg_MAD	0	0
RP3128_400 mg_MAD	0	0
Proof of Concept	0	0

Primary outcome: Number of Participants With Adverse Events

Time frame: Baseline through 2 weeks. Count of participants. Unit: Participants

Measure	Pooled Placebo (SAD) n = 9	RP3128_25 mg_SAD n = 3	RP3128_50 mg_SAD n = 4	RP3128_100 mg_SAD n = 4	RP3128_200 mg_SAD n = 6	RP3128_400 mg_SAD n = 6	Pooled Placebo (MAD) n = 6	RP3128_25 mg_MAD n = 6	RP3128_100 mg_MAD n = 6	RP3128_400 mg_MAD n = 6	Proof of Concept n = 1
Value	4	1	2	4	2	4	3	1	0	2	0

Population analysed: There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 15 Days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pooled Placebo (SAD)	0 of 9 (0%)	4 of 9 (44.4%)	0 of 9
RP3128_25 mg_SAD	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
RP3128_50 mg_SAD	0 of 4 (0%)	2 of 4 (50%)	0 of 4
RP3128_100 mg_SAD	0 of 4 (0%)	4 of 4 (100%)	0 of 4
RP3128_200 mg_SAD	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
RP3128_400 mg_SAD	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Pooled Placebo (MAD)	0 of 6 (0%)	3 of 6 (50%)	0 of 6
RP3128_25 mg_MAD	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
RP3128_100 mg_MAD	0 of 6 (0%)	0 of 6 (0%)	0 of 6
RP3128_400 mg_MAD	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Proof of Concept	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Limitations and caveats (from the sponsor): There is no limitations and Caveats

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33314326Barde PJ, Viswanadha S, Veeraraghavan S, Vakkalanka SV, Nair A. A first-in-human study to evaluate the safety, tolerability and pharmacokinetics of RP3128, an oral calcium release-activated calcium (CRAC) channel modulator in healthy volunteers. J Clin Pharm Ther. 2021 Jun;46(3):677-687. doi: 10.1111/jcpt.13322. Epub 2020 Dec 11.
Individual participant dataSharing planned: No

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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 RP3128 in people with Healthy Volunteers and Asthma, run by Rhizen Pharmaceuticals SA at 1 site in Canada.

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 11 inclusion and 6 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: stopped early, as of the sponsor's last update on 4 Oct 2019. 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 Canada. 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 4 Oct 2019). 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 Participants With Adverse Events (time frame: Baseline through 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 NCT02958982, which also lists 1 linked publication.

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 4 Oct 2019.