Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effect of PTH134 at Increasing Doses in Healthy Postmenopausal Subjects

• ClinicalTrials.gov Identifier: NCT00676312
• Recruitment Status: Completed
• First Posted: May 13, 2008
• Last Update Posted: December 11, 2008
• Sponsor: Novartis
• Information provided by: Novartis

Tracking Information

• First Submitted Date: May 8, 2008
• First Posted Date: May 13, 2008
• Last Update Posted Date: December 11, 2008
• Study Start Date: May 2008
• Actual Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 12, 2008): •Safety and tolerability of ascending single doses of PTH134 over 24 hours as compared to baseline. •Pharmacokinetics after ascending single doses of PTH134, including comparison with reference drug Forteo 20 µg sc over 24 hours.
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: May 12, 2008): •Assessment of PK from PTH134 formulations over 24 hours. •Assessment of the pharmacodynamic profile of serum ionized calcium, total serum calcium, bone biomarkers with reference drug Forteo 20 µg and placebo over 24 hours.
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effect of PTH134 at Increasing Doses in Healthy Postmenopausal Subjects
• Official Title: A Partially-Blinded, Randomized, Placebo and Active Controlled, Ascending Single-Dose Crossover Phase I Study to Explore the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of PTH134 Formulated With Different Concentrations of 5-CNAC in Healthy Postmenopausal Women
• Brief Summary: This study is designed to investigate the safety and tolerability of PTH134 in healthy subjects and to assess the exposure from PTH134.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Postmenopausal Osteoporosis

Intervention

Drug: PTH134

Other Name: teriparatid

Study Arms

Experimental: 1

Cross-over treatment with increasing doses of PTH134, placebo and active comparator.

Intervention: Drug: PTH134

• Publications *: Hämmerle SP, Mindeholm L, Launonen A, Kiese B, Loeffler R, Harfst E, Azria M, Arnold M, John MR. The single dose pharmacokinetic profile of a novel oral human parathyroid hormone formulation in healthy postmenopausal women. Bone. 2012 Apr;50(4):965-73. doi: 10.1016/j.bone.2012.01.009. Epub 2012 Jan 25.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: May 12, 2008): 32
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Actual Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Healthy postmenopausal female subjects, 40 to 70 years of age and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening
• Body mass index (BMI) within the range of 19 to 32.

Exclusion Criteria:

• Smokers who report cigarette use of >= 5 cigarettes per day.
• Use of any prescription drugs or over-the-counter (OTC) medication (vitamins, herbal supplements, dietary supplements) started within the last month prior to screening.
• Previous osteoporosis treatment
• History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse

Other protocol-defined inclusion/exclusion criteria may apply

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 40 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT00676312
• Other Study ID Numbers: CPTH134A2101
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: External Affairs, Novartis
• Study Sponsor: Novartis
• Collaborators: Not Provided

Investigators

• Principal Investigator: Novartis Pharma AG, Basel; Novartis Pharma AG, Basel

• PRS Account: Novartis
• Verification Date: December 2008