A Clinical Study Investigating the Comparability of Somat... | NCT03810664

Studies
A Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations

NCT03810664

Sponsor

OPKO Health, Inc.

Status

Completed

Last Update Posted

Apr 28, 2020Actual

Enrollment

49Actual

Phase

Phase 1

Conditions

Healthy Male Volunteers

Interventions

Somatrogon

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 18, 2019Actual

Primary Completion Date

Apr 19, 2019Actual

Completion Date

Apr 19, 2019Actual

First Submitted Date

Jan 8, 2019

First Submission Date that Met QC Criteria

Jan 17, 2019

First Posted Date

Jan 22, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2020

Last Update Posted Date

Apr 28, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a Phase 1, single-center, open-label randomized, 2×2 crossover (Ref Test | Test Ref) study with a washout of two weeks to establish bioequivalence between single dose of somatrogon in a PEN to somatrogon in VIAL administered sc in healthy male volunteers.

Detailed Description

The subjects will undergo a screening period (Day -28 to -1), and when eligible for study participation will be randomized to receive one sc injection of one of two somatrogon drug product presentations on Day 0, either the PEN or VIAL presentation. A series of blood draws and study procedures will be carried out over the course of the next 10 days to evaluate the subjects. Following a two week washout period, the subjects will be brought back to the clinic to receive the other somatrogon drug product presentation, and once again followed for the next 14 days to study completion.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Somatrogon pre-filled PEN	Experimental		Drug: Somatrogon
Somatrogon frozen liquid formulation	Active Comparator		Drug: Somatrogon

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Somatrogon	Drug	A single dose of 12 mg of somatrogon will be injected as one sc injection to the arm on each dosing day (Day 0 and Day 14).	Somatrogon frozen liquid formulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the curve (AUC) of the serum concentration-time from time 0 to a specific time (AUCt)		30 days
Area under the curve (AUC) of the serum concentration-time from time 0 to infinity (AUC∞)		30 days
Serum concentration from of maximum concentration (Cmax) of somatrogon levels in serum		30 days

Secondary Outcomes

Measure	Description	Time Frame
AUCt of IGF-1 and IGFBP-3 levels		30 days
AUC∞ of IGF-1 and IGFBP-3 levels		30 days
Cmax of IGF-1 and IGFBP-3 levels

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male volunteers aged 18-55 (inclusive) years
Body Mass Index (BMI) 19 to 32 kg/m2 (inclusive) and weighing at least 55 kg
Non-smoking (by declaration) for a period of at least six months prior to screening visit

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Healthy male volunteers

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sandra Pagnusset, MD	QPS Miami Research Associates	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
QPS Miami Research Associates		Miami	Florida	33143	United States

Intervention Browse Module

MeSH Terms

ID	Term
C000723339	somatrogon

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description