Safety Study of an Oral Vitamin D Analog in Postmenopausal Women

Sponsor

Deltanoid Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01969656

Collaborator

(none)

Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postmenopausal Osteoporosis, Multiple Sites	Drug: 2MD Drug: Calcitriol Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Official Title:

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

Actual Primary Completion Date :

Jun 1, 2004

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Change from baseline in total serum calcium [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 [1, 2, 3, 12, 18 and 24 h after the initial dose on Day 0 and after the final dose on Day 27]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 80 Years

Sexes Eligible for Study:

Female

Inclusion Criteria:

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.
Within ±30% of their ideal body weight for height and body frame.
Demonstrated ability to understand and willingness to sign an Informed Consent Form.
24-hour urinary Ca ≤250 mg/day and a urinary Ca:Cr ≤0.35.
Negative urine test for selected drugs of abuse.
Willing to maintain a total calcium intake between 700 and 1000 mg/day.

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Deltanoid Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Deltanoid Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01969656

Other Study ID Numbers:

2MD-3H-1B/C

First Posted:

Oct 25, 2013

Last Update Posted:

Jul 27, 2017

Last Verified:

Jul 1, 2017

Keywords provided by Deltanoid Pharmaceuticals

vitamin D analog

Additional relevant MeSH terms:

Osteoporosis

Osteoporosis, Postmenopausal

Calcitriol

Study Results

No Results Posted as of Jul 27, 2017