NCT06357520

Brief Summary

The main purpose of this study is to assess the effect of itraconazole on the pharmacokinetic (PK) of baxdrostat.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2024

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

April 16, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

April 5, 2024

Last Update Submit

July 2, 2024

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

  • Area Under Plasma Concentration-Time Curve From Time Zero To Infinity (AUCinf)

    The effect of itraconazole on the PK (AUCinf) of baxdrostat will be assessed.

    Period 1: Days 1 to 6 (pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, and 120 hours post-dose); Period 3: Days 9 to 17 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours)

  • Maximum Observed Plasma Drug Concentration (Cmax)

    The effect of itraconazole on the PK (Cmax) of baxdrostat will be assessed.

    Period 1: Days 1 to 6 (pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, and 120 hours post-dose); Period 3: Days 9 to 17 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours)

Secondary Outcomes (12)

  • Extrapolated Area Under The Curve From Tlast to Infinity (AUCextr)

    Period 1: Days 1 to 6 (pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, and 120 hours post-dose); Period 3: Days 9 to 17 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours)

  • Area Under Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast)

    Period 1: Days 1 to 6 (pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, and 120 hours post-dose); Period 3: Days 9 to 17 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours)

  • Apparent Total Body Clearance (CL/F)

    Period 1: Days 1 to 6 (pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, and 120 hours post-dose); Period 3: Days 9 to 17 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours)

  • Apparent Volume Of Distribution Based On The Terminal Phase (Vz/F)

    Period 1: Days 1 to 6 (pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, and 120 hours post-dose); Period 3: Days 9 to 17 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours)

  • Terminal Elimination Half-life (t1/2λz)

    Period 1: Days 1 to 6 (pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, and 120 hours post-dose); Period 3: Days 9 to 17 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours)

  • +7 more secondary outcomes

Study Arms (1)

Baxdrostat and Itraconazole

EXPERIMENTAL

Participants will receive single dose of baxdrostat tablet orally on Day 1 in Period 1, followed by itraconazole capsule orally twice a day on Day 6 and once daily on Days 7 to 8 in Period 2, and then single dose of baxdrostat tablet orally on Day 9 with itraconazole capsule orally once daily on Days 9 to 16 in Period 3.

Drug: BaxdrostatDrug: Itraconazole

Interventions

BaxdrostatDRUG

Baxdrostat tablet will be administered orally.

Also known as: CIN-107
Baxdrostat and Itraconazole
ItraconazoleDRUG

Itraconazole capsule will be administered orally.

Baxdrostat and Itraconazole

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and/or female participants of non-childbearing potential aged 18 to 55 years with suitable veins for cannulation or repeated venipuncture.
  • All female participants must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit (Study Day -1).
  • Have a body mass index between 18 and 32 kilograms per meter square (kg/m2) inclusive and weigh greater than or equal to (\>=) 50 kilograms (kg) and less than or equal to \<=) 120 kg.

You may not qualify if:

  • History of any clinically important disease or disorder which, in the opinion of the principal investigator (PI), may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
  • History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
  • History of drug-related hepatic toxicity.
  • Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
  • History of any treatment with QT prolongation drugs.
  • History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to baxdrostat or itraconazole.
  • Participants who have previously received baxdrostat.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Brooklyn, Maryland, 21225, United States

Location

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2024

First Posted

April 10, 2024

Study Start

April 16, 2024

Primary Completion

June 17, 2024

Study Completion

June 17, 2024

Last Updated

July 3, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
More information

Locations

US(1)