NCT05763459

Brief Summary

This study follows an open-label, single arm design with two periods with rosuvastatin, digoxin and ABBV-CLS-7262

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Mar 2023

Shorter than P25 for phase_1 healthy

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

February 27, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

March 24, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2023

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2023

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

2 months

First QC Date

February 27, 2023

Last Update Submit

June 23, 2023

Conditions

Healthy

Keywords

DigoxinRosuvastatinMolecular Mechanisms of Pharmacological ActionPhysiological effects of drugs

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics of Rosuvastatin

    Area under the Curve (AUC)

    Two Weeks

  • Pharmacokinetics of Digoxin

    Area under the Curve (AUC)

    Two Weeks

Secondary Outcomes (1)

  • Safety and Tolerability

    Two Weeks

Study Arms (1)

ABBV-CLS-7262

EXPERIMENTAL

ABBV-CLS-7262 + Digoxin + Rosuvastatin

Drug: ABBV-CLS-7262

Interventions

ABBV-CLS-7262DRUG

Drug: ABBV-CLS-7262 Drug: Digoxin Drug: Rosuvastatin

ABBV-CLS-7262

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult volunteers in general good health
  • Must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures
  • Individuals between 18 and 65 years of age inclusive at the time of screening
  • BMI is ≥ 18.0 to ≤ 32.0 kg/m2
  • All male subjects who are sexually active and not surgically sterilized must agree to use an acceptable contraceptive method. Additionally, male subjects must agree to not donate sperm during the study until 30 days after the final dose of study drug
  • All female subjects who are sexually active and of childbearing potential must agree to use a highly effective contraceptive method. Additionally, female subjects must agree to not donate eggs during the study and for 30 days after the final dose of study drug.

You may not qualify if:

  • Subject who, in the opinion of the investigator, is incapable of completing study-required visits and procedures
  • Pregnant or breastfeeding.
  • Treatment with any other investigational treatment within 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AbbVie Clinical Pharmacology Research Unit (ACPRU)

Grayslake, Illinois, 60030, United States

Location

Study Design

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

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 10, 2023

Study Start

March 24, 2023

Primary Completion

May 8, 2023

Study Completion

June 2, 2023

Last Updated

June 26, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)