To evaluate the plasma pharmacokinetic properties and safety of the research medication in healthy volunteers and in Patients with Systemic Mastocytosis and Allergic Asthma.
ID
Source
Brief title
Condition
- Other condition
- Allergic conditions
- Bronchial disorders (excl neoplasms)
Synonym
Health condition
Blood and Lymphatic System Disorders ; Systemic Mastocytosis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pharmacokinetics
Secondary outcome
safety
Background summary
The research medication is a is a new, improved formulation of an existing drug
developed as a first-line maintenance therapy for the prevention and management
of clinical symptoms related to systemic mastocytosis, allergic asthma and
other mast cell associated disorders.
Study objective
To evaluate the plasma pharmacokinetic properties and safety of the research
medication in healthy volunteers and in Patients with Systemic Mastocytosis and
Allergic Asthma.
Study design
This is a Phase 1, single-center, cross-over study conducted in three parts in
24 subjects.
Intervention
The study will start with a screening. At the screening a physical examination
will take place and a few other standard medical assessments will be performed
(ECG, vital signs; spirometry). Furthermore a blood and urine sample will be
taken for laboratory tests and an alcohol breath test and drug screen will be
done.
During the stay in the clinic the subject will receive the study medication. On
several time points
blood will be taken. The subjects will be asked for possible side effects on
regular basis. Furthermore several safety assessments will be done frequently.
Finally, a follow-up phone call will take place.
Study burden and risks
Cromolyn sodium has a well-established safety profile. Side effects are rare,
minor, and reversible.
Adverse events attributable to cromolyn sodium consist of cough, nasal
congestion, nausea, sneezing, and wheezing.
Oral cromolyn sodium administered to 87 study mastocytosis patients was
associated with headache (n=4), diarrhea (n=4), pruritus (n=3), nausea (n=3),
myalgia (n=3), abdominal pain (n=2), rash (n=2), irritability (n=2), and
malaise (n=1).
High Bluff Drive 12670
San diego 92130
US
High Bluff Drive 12670
San diego 92130
US
Listed location countries
Age
Inclusion criteria
Part 1:
1.Male or female volunteers 18-45 years of age, inclusive
2.FEV1 >= 90% of predicted normal value during the screening
3.Body weight above 50 kg and Body Mass Index (BMI) of 18-25, inclusive;Part 2:
1.Male or female subjects 18-65 years of age, inclusive
2.Clinical diagnosis of Indolent Systemic Mastocytosis (ISM)
3.Stable systemic mastocytosis
4.Body weight >50 kg and BMI of 18-28, inclusive;Part 3.
1.Male or female subjects 18-45 years of age, inclusive
2.Clinical diagnosis of allergic asthma
3.Pre-bronchodilator FEV1 >= 70% predicted
Exclusion criteria
Part 1:
1. Any condition that could put the subject at risk or compromise the quality of the study data
2.An upper or lower respiratory tract infection within 4 weeks of study start
3.Current smoker ;Part 2:
1.Smouldering systemic mastocytosis, aggressive systemic mastocytosis, mast cell leukemia, or systemic mastocytosis with an associated clonal hematologic non-mast cell disorder
2.Any condition that could put the patient at risk or compromise the quality of the study data as determined by the investigator
3.History of systemic corticosteroid or immunosuppressive therapy within 6 months of study start;Part 3:
1.Any condition that could put the patient at risk or compromise the quality of the study data as determined by the investigator
2.Pollen sensitized and currently symptomatic asthma
3.Use of corticosteroids within 3 months of study start
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-000775-10-NL |
| CCMO | NL48399.056.14 |