CS-8958 Single Inhaled Dose in Elderly

NCT00657111 | Completed Phase 1 DMC

• 2 other identifiers: 07-0064CCRU 1833-174
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the safety and tolerability of an investigational inhaled flu medication, CS-8958. Study participants will include 38 elderly males and females, age 65 and older. Participants will be divided into 1 of 4 possible treatment groups (Groups A, B, C and D) to receive the study drug or placebo (substance containing no medication). Group A will receive 5 mg CS-8958, Group B will receive 10 mg CS-8958, Group C will receive 20 mg CS-8958 and Group D will receive 40mg CS-8958. Safety information will be reviewed prior to administering a higher dose of treatment. Study procedures will include blood and urine samples, ECGs (measure of heart activity), and a 7 day clinic stay. Participants will be involved in study related procedures for up to 6 weeks.

Conditions

Influenza

Keywords

influenza, elderly, United Kingdom; Vaxart

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability: treatment-emergent AEs, changes in vital signs including BP and PR, SpO2, oral body temperature, ECG, spirometry, PEFR, physical examinations, psychological assessments and laboratory parameters.

  Duration of study

Secondary Outcomes (1)

• Pharmacokinetic parameters for CS-8958 and R-125489.

  Days 1-7

Study Arms (8)

A1

EXPERIMENTAL

Subjects 01-08; 5 mg CS-8958

Drug: CS-8958 formulated as dry powder

A2

PLACEBO COMPARATOR

Subjects 01-08; placebo

Other: Placebo

B1

EXPERIMENTAL

Subjects 09-16; 10 mg CS-8958

Drug: CS-8958 formulated as dry powder

B2

PLACEBO COMPARATOR

Subjects 09-16; placebo

Other: Placebo

C1

EXPERIMENTAL

Subjects 17-24; 20 mg CS-8958

Drug: CS-8958 formulated as dry powder

C2

PLACEBO COMPARATOR

Subjects 17-24; placebo

Other: Placebo

D1

EXPERIMENTAL

Subjects 25-32; 40mg CS-8958

Drug: CS-8958 formulated as dry powder

D2

PLACEBO COMPARATOR

Subjects 25-32; placebo

Other: Placebo

Interventions

CS-8958 formulated as dry powder DRUG

CS-8958, formulated as a dry-powder and will be administered from capsules containing 5 mg CS-8958 and lactose to 25 mg (placebo) inserted into a FlowCaps inhaler device.

A1; B1; C1; D1

Placebo OTHER

placebo capsules containing 25 mg lactose

A2; B2; C2; D2

Eligibility Criteria

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

You may qualify if:

• Ambulatory male and female adults aged 65 years and older.
• Female subjects must be surgically sterile or post-menopausal (defined by a measurement of follicle stimulating hormone \[FSH\] greater than 18 mlU/mL and serum oestradiol less than 110 pmol/L (or 30 pg/mL), or by 24 consecutive months of amenorrhoea for which there is no other obvious pathological cause) and have a negative serum pregnancy test.
• No clinically significant abnormality in the ECG. QTc must be less than 450 ms and PR 120-209 ms. Any ECGs considered abnormal will be reviewed and approved by an independent cardiologist, (normal variants such as sinus arrhythmia and sinus bradycardia do no need to be independently reviewed).
• Negative results in Human Immunodeficiency Virus (HIV) antibody, Hepatitis B surface antigen (HBsAg) and Hepatitis C antibody tests.
• Negative results in urine drug screen and alcohol breath test.
• Able to understand and comply with all planned study procedures including ability to perform respiratory testing and use the inhaler device after training.
• Provide informed consent prior to any study procedures and is available for all study visits.

You may not qualify if:

• Has any malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder diagnosed or treated actively during the past 5 years.
• A history or clinical evidence of hepatic disease, including abnormal laboratory values for AST, ALT or total bilirubin or abnormal laboratory values for potassium.
• A history or clinical evidence of hematological abnormalities; specifically abnormal laboratory values for hemoglobin, platelets, WBC or neutrophils.
• A history or clinical evidence of renal disease; specifically abnormal laboratory values for serum creatinine.
• A history or clinical evidence of ventricular arrhythmias, or any subject with an implantable defibrillator.
• A history or clinical evidence of significant respiratory disease (including asthma, hyper-reactive lung disease, COPD \[on oral steroids or with chronic bronchitis\], cystic fibrosis and/or recurrent lower respiratory tract infection, pneumonectomy or pulmonary insufficiency requiring home O2) and/or upper respiratory tract infection within the last 3 weeks or lower respiratory tract infection within the last 3 months.
• Any diagnosis of dementia (such as Alzheimer's disease) or current treatment for dementia (e.g. Aricept), or a mini mental state score of less than or equal to 25 at Screening.
• A Geriatric Depression Scale-Short Form (GDS-SF) score of greater than or equal to 6 (out of a total possible score of 15) at Screening, or a history or clinical evidence of endogenous depression, or a history or clinical evidence or treatment of exogenous depression within 1 year prior to enrollment in this study.
• A score of less than or equal to 16 out of 20 in the Clock Drawing Test (CDT) on Day 0.
• Has an acute or chronic medical condition that in the opinion of the Investigator would interfere with the evaluation of response.
• Is using parenteral or oral steroids, inhaled medications, anticoagulants, immune modulators (oral or topical) or other immunosuppressive or cytotoxic drugs within 2 weeks prior to enrolment in this study.
• Has received any other neuraminidase inhibitor within 2 weeks prior to enrollment in this study.
• A history or clinical evidence of dizziness with unknown cause.
• History of severe adverse reaction or hypersensitivity to lactose or neuraminidase inhibitors.
• Intake of any investigational drug product within 4 months prior to the intake of investigational product (Day 1).

Sponsors & Collaborators

• Biota Scientific Management Pty Ltd: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Covance Clinical Research Unit Ltd (Covance CRU)

Leeds, LS2 9LH, United Kingdom

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Douglas ET Lee, MBChB MRCP DGM

  Covance CRU

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 10, 2008
• First Posted: April 14, 2008
• Study Start: April 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: September 17, 2018

Record last verified: 2018-09

Locations

GB (1)