An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)
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| ClinicalTrials.gov Identifier: NCT03789656 |
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Recruitment Status :
Completed
First Posted : December 28, 2018
Last Update Posted : November 4, 2020
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Sponsor:
Crinetics Pharmaceuticals Inc.
Information provided by (Responsible Party):
Crinetics Pharmaceuticals Inc.
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Brief Summary:
An open label exploratory study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly that are treated with somatostatin analogue (SSA) based treatment regimens.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acromegaly | Drug: Paltusotine | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 47 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open Label Exploratory Study to Evaluate the Safety, Pharmacokinetics and Efficacy of CRN00808 in Patients With Acromegaly Treated With Somatostatin Analogue Based Treatment Regimens (ACROBAT Edge) |
| Actual Study Start Date : | January 15, 2019 |
| Actual Primary Completion Date : | August 3, 2020 |
| Actual Study Completion Date : | August 31, 2020 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: Paltusotine |
Drug: Paltusotine
Paltusotine, capsules, once daily by mouth
Other Name: CRN00808 |
Primary Outcome Measures :
- Change from baseline (mean of Screening values) in insulin-like growth factor-1 (IGF-1) level [ Time Frame: 13 Weeks ]
Secondary Outcome Measures :
- Proportion of subjects with their last IGF-1 measurement ≤ upper limit of normal (ULN) [ Time Frame: 13 Weeks ]
- Proportion of subjects with their last IGF-1 measurements ≤1.5×ULN [ Time Frame: 13 Weeks ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female subjects 18 to 70 years of age
- Confirmed diagnosis of acromegaly with either a partial or complete response to protocol defined somatostatin analogue therapy regimens
- Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control
- Willing to provide signed informed consent
Exclusion Criteria:
- Treatment naïve acromegaly subjects
- Prior treatment with paltusotine
- Pituitary surgery within 6 months prior to Screening. Subjects receiving radiation therapy may be eligible with some restrictions.
- History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years
- Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer
- Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab) or has a history of a positive result
- History of alcohol or substance abuse in the past 12 months
- Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study
- Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities
- Subjects with symptomatic cholelithiasis
- 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
- Subjects taking octreotide LAR at a dose higher than 40 mg, or lanreotide depot at a dose higher than 120 mg, or pasireotide LAR at a dose higher than 60 mg
- Subjects who usually take octreotide LAR or lanreotide depot less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789656
Locations
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Sponsors and Collaborators
Crinetics Pharmaceuticals Inc.
| Responsible Party: | Crinetics Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT03789656 |
| Other Study ID Numbers: |
CRN00808-03 2018-002230-20 ( EudraCT Number ) |
| First Posted: | December 28, 2018 Key Record Dates |
| Last Update Posted: | November 4, 2020 |
| Last Verified: | November 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Crinetics Pharmaceuticals Inc.:
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Acromegaly ACROBAT EDGE Paltusotine |
Additional relevant MeSH terms:
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Acromegaly Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Pituitary Diseases |
Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases |