Healthy VolunteersPhase 1ABBV-576 DDINCT05530278

A Study to Assess the Pharmacokinetics and Safety of Co-administered Oral Galicaftor, Navocaftor, and ABBV-576 in Healthy Adults for the Treatment of Cystic Fibrosis

A Phase 1 study testing Galicaftor, ABBV-576 and Navocaftor in people with Healthy Volunteers, run by AbbVie at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Galicaftor, ABBV-576 and Navocaftor
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 4 sitesUnited States
Study dates: 20 Sep 2022to 29 Nov 2022
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounding to the tenths decimal.
A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).

Who cannot join

History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
History of any clinically significant sensitivity or allergy to any medication or food.
History of any clinically significant condition listed in the protocol.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Anaheim Clinical Trials LLC /ID# 248824
Anaheim, California, 92801-2658
PPD Clinical Research Unit - Austin /ID# 248854
Austin, Texas, 78744
PPD Clinical Research Unit -Las Vegas /ID# 248853
Las Vegas, Nevada, 89113-2235
Clinical Pharmacology of Miami /ID# 248823
Miami, Florida, 33014

Other trials in United States

About this study

Official title: Assessment of Multiple-Dose Pharmacokinetics and Safety of the Co-administration of Galicaftor, Navocaftor and ABBV-576 and Potential of ABBV-576 for CYP3A Induction in Healthy Volunteers

Cystic Fibrosis (CF) is a rare, life-threatening, genetic disease that affects the lungs and digestive system, significantly impairing the quality of life, with those affected having a median age of death at 40. The main objectives of this study are to assess the safety and pharmacokinetics of the combination therapy of galicaftor/navocaftor/ABBV-576.

Conditions: Healthy Volunteers
Being tested: Galicaftor, ABBV-576, Navocaftor, Midazolam
Keywords: Galicaftor, Navocaftor, ABBV-576, Cystic Fibrosis
Medical subject headings: Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GalicaftorDrug
Oral
ABBV-576Drug
Oral
NavocaftorDrug
Oral
MidazolamDrug
Oral

Study groups in NCT05530278
Study group	Role	What they receive
ABBV-576 with Galicaftor + Navocaftor	Experimental	Participants will receive ABBV-576 for 14 consecutive days, with navocaftor + galicaftor for the latter 7 consecutive days. Receives: Drug: Galicaftor; Drug: ABBV-576; Drug: Navocaftor
Navocaftor + Galicaftor with ABBV 576	Experimental	Participants will receive Navocaftor + galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days. Receives: Drug: Galicaftor; Drug: ABBV-576; Drug: Navocaftor
Optional: Navocaftor with ABBV 576	Experimental	Participants will receive Navocaftor for 14 consecutive days with ABBV 576 for the latter 7 consecutive days. Receives: Drug: ABBV-576; Drug: Navocaftor
Optional: Galicaftor with ABBV 576	Experimental	Participants will receive Galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days. Receives: Drug: Galicaftor; Drug: ABBV-576
Optional: Midazolam with ABBV-576 + Navocaftor	Experimental	Participants will receive Midazolam alone and in combination with multiple doses of ABBV-576 + navocaftor. Receives: Drug: ABBV-576; Drug: Navocaftor; Drug: Midazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Plasma Concentration (Cmax)
Cmax will be assessed.
Measured: Up to Day 52
Time to maximum observed plasma concentration (Tmax)
Tmax will be assessed.
Measured: Up to Day 52
Apparent terminal phase elimination rate constant (BETA or β)
Apparent terminal phase elimination rate constant (BETA or β) will be assessed.
Measured: Up to Day 52
Mean terminal phase elimination half-life (t1/2)
T1/2 will be assessed.
Measured: Up to Day 52
Area under the plasma curve (AUC)
AUC will be assessed.
Measured: Up to Day 52
Number of Participants With Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Measured: Up to Day 82

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Sep 202229 Nov 2022

First posted7 Sep 2022
Study start20 Sep 2022
Primary completion29 Nov 2022
Study completion29 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05530278
Sponsor's protocol ID: M20-974
Acronym: ABBV-576 DDI
Status last verified: Feb 2023
First submitted: 5 Sep 2022
Last updated: 21 Feb 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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