A Study to Evaluate the Effects of SB-751689 or rhPTH(1-34) on Excretion of Calcium and Phosphate in Women

NCT00532077 | Completed Phase 1

• 1 other identifier: CR9108122
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief Summary

SB-751689 may alter calcium and phosphate handling at the kidney level. This study will examine what happens to calcium and phosphate, and other electrolytes, at the kidney after treatment with SB-751689 for 1 month. Another group of subjects will get another drug called Forteo for 1 month to compare the response of the kidney for calcium and phosphate.

Conditions

Osteoporosis

Keywords

renal,; pharmacology,; Osteoporosis

Outcome Measures

Primary Outcomes (1)

• renal fractional clearance of calcium and phosphate

  over 1 month

Secondary Outcomes (7)

• renal fraction clearance of electrolytes, cAMP, safety measures, and serum biomarkers

  over 1 month

• urinary excretion of sodium, magnesium, potassium, bicarbonate, and chloride

• Albumin-adjusted serum calcium levels

• Vitamin D and P1NP levels

• Plasma levels of SB-751689 and rhPTH(1-34)

Interventions

rhPTH(1-34) DRUG

SB-751689 100 mg DRUG

SB-751689 400 mg DRUG

Also known as: rhPTH(1-34), SB-751689 100 mg

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy postmenopausal women 40 to 65 years of age, inclusive, meeting at least one of the following: Postmenopausal defined by the STRAW criteria of 12 months of spontaneous amenorrhea with serum FSH levels = 40 mIU/mL; History of bilateral oophorectomy (with or without hysterectomy) and at least 6 weeks post-surgical with serum FSH levels = 40 mIU/mL
• Body weight \> 50 kg and BMI within the range 19 - 32 kg/m2
• Capable of giving written informed consent

You may not qualify if:

• Any clinically relevant biological or physical abnormality found or reported at screening which, in the opinion of the investigator, is clinically significant and would preclude safe participation in this study. These abnormalities may be identified on the screening history and physical or laboratory examination and 12-lead electrocardiogram (ECG).
• A subject may not participate in the study if any of the following laboratory results are above the upper limit of the normal range at screening: liver function tests (ALT, AST, GGT, alkaline phosphatase, total bilirubin), plasma amylase, glucose, alkaline phosphatase, or CPK.
• A subject may not participate in the study if any of the following laboratory results are outside the normal range at screening: serum levels of albumin-adjusted calcium, total calcium, PTH, and urinary calcium.
• A subject with vitamin D deficiency as defined by serum 25-hydroxy vitamin D \< 20 ng/mL (equivalent to 50 nmol/L) at screening may not participate in the study. A QTc interval \> 450 msec at screening.
• Positive urine drug screen.
• Positive for HIV, hepatitis B virus or hepatitis C virus assays.
• Urinary cotinine levels indicative of smoking.
• History of smoking or use of nicotine containing products within one year of screening.
• History of regular alcohol consumption
• History of drug abuse within 6 months of the study.
• Participation in a study with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
• Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
• Use of prescription or non-prescription drugs, calcium containing antacids, aspirin or nonsteroidal anti-inflammatory drugs, vitamins, herbal and dietary supplements, excluding study related vitamin D and calcium supplements, within 14 days prior to the first dose of study medication.
• Donation of blood in excess of 500 mL within 56 days prior to dosing.
• Evidence of hepatic or biliary disease (including cholecystectomy and Gilbert's Syndrome).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (5)

GSK Investigational Site

San Diego, California, 92123, United States

Location

GSK Investigational Site

Daytona Beach, Florida, 32117, United States

Location

GSK Investigational Site

Port Orange, Florida, 32127, United States

Location

GSK Investigational Site

Honolulu, Hawaii, 96813, United States

Location

GSK Investigational Site

Austin, Texas, 78752, United States

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• GSK Clinical Trials, MD

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 17, 2007
• First Posted: September 19, 2007
• Study Start: August 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: October 19, 2010

Record last verified: 2010-10

Locations

US (5)