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

NCT02958982 | Terminated Phase 1 Results DMC

• 1 other identifier: RP3128-1601
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers; Asthma

Keywords

RP3128; Phase 1; Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

  Baseline through 2 weeks

Secondary Outcomes (6)

• Peak Plasma Concentration (Cmax)

  Pre-dose through 48 hours post dose

• Measurement of Cytokines

  Predose and Day 7 in Part 2

• Fractional Exhaled Nitric Oxide (FeNo)

  Prechallenge to 3, 8 and 24 hours post challenge in Part 3

• Area Under Effective Concentration (AUEC)

  0 to 3 hours and 3 to 8 hours post allergen challenge in Part 3

• Cell Count

  8 and 24 hours post allergen challenge in Part 3

Study Arms (2)

RP3128

EXPERIMENTAL

RP3128, A CRAC channel modulator

Drug: RP3128

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

RP3128 DRUG

Participants will receive single oral dose of RP3128 in SAD, multiple dose in MAD AND POC

Also known as: CRAC channel modulator

RP3128

Placebo DRUG

Participants will receive single oral dose of RP3128 in SAD, multiple dose in MAD AND POC

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Rhizen Pharmaceuticals SA: lead

Study Sites (1)

Inflamax Research Inc.

Mississauga, Ontario, L4W 1A4, Canada

Location

Related Publications (1)

• 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.

  PMID: 33314326 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

RP3128

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

There is no limitations and Caveats

Results Point of Contact

• Title: Dr. Prajak Barde
• Organization: Rhizen Pharmaceuticals S.A.

pjb@rhizen.com

+41 32 580 0113

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 8, 2016
• Study Start: November 3, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: October 4, 2019
• Results First Posted: October 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)