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Trial record 1 of 1 for:    Safety, Tolerability and Pharmacokinetics of Oral Doses of RP3128 of Rhizen Pharmaceuticals
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Safety, Tolerability and Pharmacokinetics of Oral Doses of RP3128 of Rhizen Pharmaceuticals

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ClinicalTrials.gov Identifier: NCT02958982
Recruitment Status : Terminated (Significant recruitment delay in POC part)
First Posted : November 8, 2016
Results First Posted : October 4, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Rhizen Pharmaceuticals SA

Brief 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 patients with mild asthma.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Asthma Drug: RP3128 Drug: Placebo Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : November 3, 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: RP3128
RP3128, A CRAC channel modulator
Drug: RP3128
Participants will receive single oral dose of RP3128 in SAD, multiple dose in MAD AND POC
Other Name: CRAC channel modulator

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Participants will receive single oral dose of RP3128 in SAD, multiple dose in MAD AND POC




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) [ Time Frame: Pre-dose through 48 hours post dose ]
    Cmax after administration of RP3128/ placebo in part 1 and part 2

  2. Measurement of Cytokines [ Time Frame: Predose and Day 7 in Part 2 ]
    Levels of cytokines following LPS (lipopolysaccharide) or CD3/CD28 stimulation.

  3. Fractional Exhaled Nitric Oxide (FeNo) [ Time Frame: Prechallenge to 3, 8 and 24 hours post challenge in Part 3 ]
    Change in FeNo after administration of RP3128/ placebo in part 3

  4. Area Under Effective Concentration (AUEC) [ Time Frame: 0 to 3 hours and 3 to 8 hours post allergen challenge in Part 3 ]
    AUEC0-3h, AUEC3-8h after administration of RP3128/ placebo in part 3

  5. Cell Count [ Time Frame: 8 and 24 hours post allergen challenge in Part 3 ]
    Absolute and % counts of sputum eosinophils and neutrophils

  6. Area Under the Plasma-Concentration [ Time Frame: Pre-dose through 48 hours post dose ]
    AUC0-t after administration of RP3128/ placebo in part 1 and part 2



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958982


Locations
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Canada, Ontario
Inflamax Research Inc.
Mississauga, Ontario, Canada, L4W 1A4
Sponsors and Collaborators
Rhizen Pharmaceuticals SA
  Study Documents (Full-Text)

Documents provided by Rhizen Pharmaceuticals SA:
Study Protocol  [PDF] December 27, 2017
Statistical Analysis Plan  [PDF] June 22, 2017

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rhizen Pharmaceuticals SA
ClinicalTrials.gov Identifier: NCT02958982    
Other Study ID Numbers: RP3128-1601
First Posted: November 8, 2016    Key Record Dates
Results First Posted: October 4, 2019
Last Update Posted: October 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rhizen Pharmaceuticals SA:
RP3128
Phase 1
Healthy volunteers