Red Blood Cell Precursor Formulation to Determine Increased Production

NCT ID: NCT01701531

Last Updated: 2016-05-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-05-31

Brief Summary

The objective of this study is to measure the change in hemoglobin levels after the administration of an amino acid based, RBC precursor formulation.

Detailed Description

Medical foods are a distinct FDA regulatory category different from single molecule chemical pharmaceuticals, and from dietary supplements. The FDA has regulated amino acid preparations as drugs since the 1940s as they can elicit pharmacologic effects similar to conventional single molecule pharmaceuticals. The best known amino acid preparations are used to treat conditions such as maple syrup disease and phenylketonuria (PKU). An official definition and categorization of medical foods was made in 1988 as part of the Orphan Drug Act. Medical foods are regulated similarly to drugs except they do not require pre-approval because all ingredients are found on the FDA's generally recognized as safe (GRAS) (Sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act) list and claims are confined to the nutritional management of a specific disease. Medical food claims must be supported by recognized scientific data as determined by medical evaluation. A GRAS substance is distinguished from a food additive on the basis of the common knowledge about the safety of the substance for its intended use. The standard for an ingredient to achieve GRAS status requires not only technical demonstration of non-toxicity and safety, but also general recognition of safety through widespread usage and agreement of that safety by experts in the field. Many ingredients have been determined by the FDA to be GRAS, and are listed as such by regulation, in Volume 21 Code of Federal Regulations (CFR) Sections 182, 184, and 186.

Conditions

Anemia

Study Design

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

Study Groups

RBCPF

Treatment intervention arm

Group Type: EXPERIMENTAL

RBCPF

Intervention Type: DRUG

Interventions

RBCPF

Intervention Type: DRUG

Other Intervention Names

Red blood cell precursor formulation

Eligibility Criteria

Inclusion Criteria

1. M/F patients 18 to 75 years old, non-pregnant/lactating

2. Male patients with < Hemoglobin of 12.5

3. Female Patients with < Hemoglobin of 11

4. Diagnosis of mild to moderate anemia by study physician

Exclusion Criteria

1. Pregnant or unwilling to use adequate birth control for the duration of the study.

2. Unwilling or unable to sign informed consent.

3. Myocardial infarction within the last 6 months.

4. Patients currently taking an erythropoietin medication and unable to discontinue for the duration of the study.

5. GI bleed in the last 6 months.

6. Inflammatory bowel disease.

7. Chronic liver disease.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Targeted Medical Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lawrence May, MD

Role: PRINCIPAL_INVESTIGATOR

Lawrence May MD, Inc

Locations

Lawrence May, MD, Inc.

Tarzana, California, United States

Countries

United States

Other Identifiers

RBC100312

Identifier Type: -

Identifier Source: org_study_id