A study to evaluate safety and processing by body of GDC-6988 in healthy adults receiving albuterol as a pretreatment medicatio

Phase 1

• Conditions: Safety and pharmacokinetics of multiple ascending doses of GDC-6988 with and without albuterol pretreatment in healthy adult subjects; Not Applicable

• Registration Number: ISRCTN15406513
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-07
• Last Update Posted: 5 August 2022
• Study Completion: 2022-12-19

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Age 18 - 55 years at time of signing Informed Consent Form
2. Body mass index of 18 - 32 kilograms per square metre (kg/m²) at screening
3. Body temperature of 35°C - 37.5°C at screening and at Day-1
4. Systolic blood pressure of 90 - 150 millimetres of mercury (mmHg) and diastolic blood pressure of 50 - 95 mmHg at screening and at Day-1. Blood pressure should be measured while the participant is in a seated position.
5. Forced expiratory volume in 1 second (FEV1) >80% of predicted at screening and at Day-1
6. Forced vital capacity (FVC) >2.0 L by spirometry at screening

Exclusion Criteria

1. Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 28 days after the final dose of study drug
2. Treatment with investigational therapy (or blinded comparator) within 90 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug
3. Treatment with any immunosuppressive medication within 28 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug
4. Treatment with an herbal or homoeopathic remedy within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study drug
5. Treatment with any vaccine within 14 days prior to initiation of study drug or a scheduled vaccination during study period (through the follow-up/early termination visit)
6. Positive for tuberculosis (TB) during screening or within 3 months prior to screening, defined as a positive QuantiFERON®-TB Gold test (QFT)
7. Positive human immunodeficiency virus (HIV) test at screening
8. Positive hepatitis B surface antigen (HBsAg) test at screening
9. Positive hepatitis C virus (HCV) antibody test at screening
10. Receipt of blood products within 120 days prior to screening
11. Hospitalisation within 28 days prior to initiation of study drug
12. Anticipation of need for a surgical procedure during the study
13. Infection requiring oral or intravenous (IV) antibiotics within 28 days prior to screening or any evidence of current infection (e.g., bacterial, viral, fungal)
14. Upper or lower respiratory tract infection within 2 weeks prior to initiation of study drug
15. Documented physician-diagnosed asthma for at least 12 months prior to screening
16. Post-bronchodilator reversibility of FEV1 (litres) =12% and =200 mL at screening
17. Any medical condition or abnormal clinical laboratory finding that, in the investigator's judgement, would preclude the participant's safe participation in and completion of the study or could affect the interpretation of the results
18. History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer
19. History of any significant drug or food allergy (e.g., allergic reactions that resulted in anaphylaxis or hepatotoxicity)
20. History of symptomatic bradycardia
21. History of ataxia or condition associated with ataxia
22. Abnormally low total lung capacity, defined as <80% of predicted for participants of European descent or <75% of predicted for participants of non-European descent, at screening
23. Diffusion capacity of the lung for carbon monoxide, defined as <75% of predicted for participants of European descent or <70% of predicted for participants of non-European descent, at screening
24. Glomerular filtration rate <80 millilitres per minute (mL/min)/1.73 square metre (m^2) as calculated through use of the Chronic Kidney Disease Epidemiology Collaboration equation. Participants with a glomerular filtration rate =80 mL/min/1.73 m² and <90 mL/min/1.73 m² are eligible only if have confirmed cystatin C value below upper limit of normal (ULN)

Study & Design

• Study Type: Interventional
• Study Design: Not specified