Safety Study of an Oral Vitamin D Analog in Postmenopausal Women

July 25, 2017 updated by: Deltanoid Pharmaceuticals

A Phase 1B, Double-Blind, Placebo-Controlled, Calcitriol Active-Controlled, Daily-Dose, Escalating-Dose, Safety and Tolerance Study of 2MD Soft Gel Capsules in Normal Healthy Postmenopausal Women

Determine the safety of 2MD, a vitamin D analog, when administered orally once daily for 28 days in healthy normal postmenopausal women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Normal healthy postmenopausal women, ≥ 60 but ≤ 80 years of age, or between 45 and 60 years of age who have been amenorrheic for at least 2 years plus have a serum FSH level of > 30 IU/L, or women with a documented bilateral oophorectomy at least 2 years prior to study start.
  2. Within ±30% of their ideal body weight for height and body frame.
  3. Demonstrated ability to understand and willingness to sign an Informed Consent Form.
  4. 24-hour urinary Ca ≤250 mg/day and a urinary Ca:Cr ≤0.35.
  5. Negative urine test for selected drugs of abuse.
  6. Willing to maintain a total calcium intake between 700 and 1000 mg/day.

Exclusion Criteria:

  1. Any acute or chronic condition that would limit the subject's ability to complete the study.
  2. Active clinical manifestations of significant metabolic, hematological, pulmonary, hepatic, cardiovascular, gastrointestinal (including malabsorption), neurological, renal, urological or psychiatric disorders.
  3. History or presence of any diseases known or believed to influence calcium absorption or metabolism.
  4. History of renal calculi.
  5. History of an eating disorder.
  6. History of stomach or intestinal surgery.
  7. History of hypersensitivity or allergies to any vitamin D derivative.
  8. History or presence of an abnormal ECG.
  9. Use of any medications or products affecting vitamin D metabolism within 6 months prior to study entry.
  10. Use of any medications or products affecting calcium balance or bone turnover within 6 months prior to study entry.
  11. Participation in any other investigational study drug trial in which receipt of investigational study drug occurred within 60 days prior to study entry.
  12. Use of vitamin and/or mineral supplements >1X RDI within 4 weeks prior to study entry, unless deemed acceptable by Investigator.
  13. Poor peripheral venous access.

  14. Receipt of blood products within 2 months prior to study entry.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Active Comparator: Calcitriol
Drug: Calcitriol
Experimental: 50 ng 2MD
Drug: 2MD
Experimental: 110 ng 2MD
Drug: 2MD
Experimental: 170 ng 2MD
Drug: 2MD
Experimental: 220 ng 2MD
Drug: 2MD
Experimental: 440 ng 2MD
Drug: 2MD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in total serum calcium
Time Frame: Days 0 (pre-dose), 1, 2, 3, 7, 14, 21, 27, 28 and 2 weeks after last dose
Days 0 (pre-dose), 1, 2, 3, 7, 14, 21, 27, 28 and 2 weeks after last dose
Change from baseline in levels of 2MD in the blood
Time Frame: 1, 2, 3, 12, 18 and 24 h after the initial dose on Day 0 and after the final dose on Day 27
1, 2, 3, 12, 18 and 24 h after the initial dose on Day 0 and after the final dose on Day 27

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deltanoid Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

October 22, 2013

First Submitted That Met QC Criteria

October 24, 2013

First Posted (Estimate)

October 25, 2013

Study Record Updates

Last Update Posted (Actual)

July 27, 2017

Last Update Submitted That Met QC Criteria

July 25, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2MD-3H-1B/C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postmenopausal Osteoporosis, Multiple Sites

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe