A Study to Investigate How the Study Drug SHP626 is Eliminated From the Body After One Dose

NCT ID: NCT02571192

Last Updated: 2019-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-01
• Study Completion Date: 2015-10-01

Brief Summary

The purpose of this study is to determine how SHP626 is absorbed and excreted from the body in healthy males.

Conditions

Non-Alcoholic Steatohepatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Experimental Drug

single oral dose radiolabelled 50mg of SHP626

Group Type: EXPERIMENTAL

SHP626

Intervention Type: DRUG

single oral dose 50mg SHP626 with approximately 5.95 μCi RAD

5.95 μCi RAD

Intervention Type: RADIATION

Interventions

SHP626

single oral dose 50mg SHP626 with approximately 5.95 μCi RAD

Intervention Type: DRUG

5.95 μCi RAD

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. Age between 18 and 50 years, inclusive, at the time of consent.

2. Must be considered healthy. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, thyroid panel (includes T3, T4 and TSH at Screening only), blood chemistry, coagulation and urinalysis

3. Must have a body mass index between 18.0-30.0kg/m² inclusive with a body weight >50 kg (110 lbs).

4. Ability to swallow all investigational product.

5. A minimum of 1 bowel movement per day.

Exclusion Criteria

1. History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gallbladder removal, gastric bypass surgery, ileal resection, any small intestinal resection,or current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments.

2. Current or relevant history of physical or psychiatric illness.

3. Known or suspected intolerance or hypersensitivity to the investigational product, or closely-related compounds, or any of the stated ingredients.

4. Significant illness, as judged by the investigator, within 2 weeks of the dose of investigational product.

5. Known history of alcohol or other substance abuse within the last year.

6. Donation of blood or blood products (eg, plasma or platelets) within 60 days prior to the dose of investigational product.

7. Within 30 days prior to the dose of investigational product:

• Have used an investigational product (if elimination half-life is <6 days, otherwise 5 half-lives).
• Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study.
• Have had any substantial changes in eating habits, as assessed by the investigator.

8. Confirmed systolic blood pressure >139mmHg or <89mmHg, and diastolic blood pressure >89mmHg or <49mmHg.

9. Twelve-lead ECG demonstrating QTc >450 msec at screening. If QTc exceeds 450msec, the ECG should be repeated 2 more times and the average of the 3 QTc values should be used to determine the subject's eligibility.

10. A positive screen for drugs of abuse at Screening or a positive screen for alcohol or drugs of abuse at Check-in (Day -1).

11. Male subjects who consume more than 21 units of alcohol per week or 3 units of alcohol per day.

12. A positive human immunodeficiency virus antibody screen, hepatitis B surface antigen, or hepatitis C virus antibody screen.

13. Use of tobacco in any form

14. Routine consumption of more than 2 units of caffeine per day

15. Current use of any medication including over-the-counter, herbal, or homeopathic preparations

16. An inability to follow a standardized diet and meal schedule or inability to fast

17. Have participated in a [14C]-study within the last 6 months prior to the dose of investigational product.

18. Exposure to clinically significant radiation within 12 months prior to the dose of investigational product

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mirum Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicholas Siebers, MD

Role: PRINCIPAL_INVESTIGATOR

Covance Clinical Pharmacology

Locations

Covance Madison Clinical Research Unit

Madison, Wisconsin, United States

Countries

United States

References

Siebers N, Palmer M, Silberg DG, Jennings L, Bliss C, Martin PT. Absorption, Distribution, Metabolism, and Excretion of [14C]-Volixibat in Healthy Men: Phase 1 Open-Label Study. Eur J Drug Metab Pharmacokinet. 2018 Feb;43(1):91-101. doi: 10.1007/s13318-017-0429-7.

Reference Type: DERIVED

PMID: 28702877 (View on PubMed)

Other Identifiers

SHP626-102

Identifier Type: -

Identifier Source: org_study_id