A Phase Ib, randomized, double-blind, placebo-controlled, single-center study to evaluate the safety and pharmacokinetics of multiple ascending doses of GDC-6988 with and without albuterol pretreatment in healthy adult subjects

F. Hoffman-La Roche Ltd.0 sites41 target enrollmentAugust 9, 2022

ConditionsCystic fibrosis (CF)Nutritional, Metabolic, Endocrine Cystic fibrosis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Cystic fibrosis (CF)
Sponsor: F. Hoffman-La Roche Ltd.
Enrollment: 41
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 9, 2022

End Date

May 2, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

F. Hoffman-La Roche Ltd.

Eligibility Criteria

Inclusion Criteria

•1\. Signed Informed Consent Form
•2\. Age 18\-55 years at time of signing Informed Consent Form
•3\. Ability to comply with the study protocol
•4\. Body mass index of 18\-32 kg/m² at screening
•5\. Body temperature of 35\-37\.5 degrees C at screening and at Day \-1
•6\. Systolic blood pressure of 90 \- 150 mmHg and diastolic blood pressure of 50\-95 mmHg at screening and at Day \-1\. Blood pressure should be measured while the subject is in a seated position
•7\. Agreement to abstain from consumption of caffeine\-containing foods and beverages from 72 hours prior to clinic check\-in and during the residential stay at the clinic
•8\. Agreement to abstain from consumption of alcohol from 24 hours prior to clinic check\-in and during the residential stay at the clinic
•9\. FEV1 \>80% of predicted at screening and at Day \-1
•10\. Forced vital capacity (FVC) \>2\.0L 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. Women of childbearing potential must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result on Day \-1\.
•2\. Study site employee or immediate family member of a study site or Sponsor employee
•3\. 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
•4\. Treatment with any immunosuppressive medication within 28 days or 5 drug elimination half\-lives, whichever is longer, prior to initiation of study drug
•5\. Treatment with an herbal or homeopathic remedy within 14 days or 5 drug elimination half\-lives (whichever is longer) prior to initiation of study drug
•6\. 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)
•7\. Treatment with any other (not already described above) prescription or non\-prescription medication or dietary supplement (products taken by mouth that contain dietary ingredients such as vitamins, minerals, amino acids, herbs or botanicals) within 14 days or 5 drug elimination half\-lives, whichever is longer, prior to initiation of study drug, with the following exceptions:
•7\.1\. Oral contraceptives and hormone\-releasing intrauterine devices and hormone\-replacement therapies
•7\.2\. Acetaminophen or paracetamol at a dose of up to 2 g/day
•8\. Positive for TB during screening or within 3 months prior to screening, defined as a positive QuantiFERON®\-TB Gold test (QFT)