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Clinical Trials/CTIS2024-511921-75-00
CTIS2024-511921-75-00
Active, not recruiting
Phase 1

An open label, long-term extension study to evaluate the safety and efficacy of CRN00808 in subjects with acromegaly (ACROBAT ADVANCE) - CRN00808-05

Crinetics Pharmaceuticals Inc.0 sites31 target enrollmentJune 28, 2024

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Acromegaly
Sponsor
Crinetics Pharmaceuticals Inc.
Enrollment
31
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 28, 2024
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. Completed one of the parent studies (Acrobat Evolve (CRN00808\-02\) or Acrobat Edge (CRN00808\-03\)), 2\. Females must be non\-pregnant and non\-lactating either surgically sterile, post\-menopausal, or using effective method(s) of birth control., 3\. Willing to provide signed informed consent

Exclusion Criteria

  • 1\. Clinically significant concomitant disease including, but not limited to, cardiovascular disease; moderate or severe renal insufficiency; or significant liver disease (including cirrhosis), 10\. Subjects with clinically significant abnormal findings during the Screening Period, and any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the subject's safety or ability to complete the study, 2\. Pituitary radiation since completing participation in parent studies, 3\. History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 year, 4\. Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV\-Ab)., 5\. History of alcohol or substance abuse in the past 12 months, 6\. Use of any investigational drug (other than paltusotine) within the past 30 days or 5 half\-lives, whichever is longer before Screening, 7\. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study., 8\. Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities, 9\. Subjects with symptomatic cholelithiasis

Outcomes

Primary Outcomes

Not specified

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