Dose-finding study of kratom alkaloids pilot

Ended Definitive Contract Awarded Last action

Contract number
75F40121C00199
Awardee
Awarding agency
Obligated
$2,370,057

Award facts

Opportunity
  • RFPFDA1238584 Solicitation number
Contract value 100% obligated
$2,370,057.00 Current and potential, with all options
Completion date 100% complete
Current and potential, with all options
Contracting staff
Set-aside
No set-aside
Competition
Full and Open Competition · 1 offer Negotiated Proposal / Quote
Pricing
Firm Fixed Price
Place of performance
Silver Spring, MD 20903, USA

Award details come from SAM.gov/FPDS.

Transactions

Action Obligated Date
Other Administrative Action P00005 · No cost modification to change the period of performance end date to march 30, 2025 $0
Funding Only Action P00004 · Ratification of an unauthorized commitment for the dose finding study of kratom alkaloids pilot $25,000
Other Administrative Action P00003 · IPP modification $0
Other Administrative Action P00002 $0
Other Administrative Action P00001 $0
Original award $2,345,057

About this award

Altasciences Clinical Kansas Inc., a clinical research organization specializing in pharmaceutical and pharmacological studies, was awarded a $2.37M firm fixed-price definitive contract by the Food and Drug Administration (FDA) for a dose-finding study of kratom alkaloids pilot. The contract, awarded on September 30, 2021, with performance to be completed by March 30, 2025, was not set aside for small businesses. Work will be performed in Silver Spring, Maryland. As a child entity within a larger corporate structure, Altasciences Clinical Kansas brings extensive expertise in conducting complex clinical trials, particularly in substance use disorder research and pharmacological investigations.

This contract exemplifies the FDA's investment in rigorous pharmacological research for botanical compounds. Altasciences Clinical Kansas holds a substantial track record with federal agencies, including a $21M indefinite delivery contract with the National Institute on Drug Abuse (NIDA) focused on pharmacokinetic and pharmacodynamic trials supporting medication development for substance use disorders. The company's portfolio demonstrates consistent competitiveness in the open market, having been awarded multiple prime contracts from both NIDA and the FDA for specialized clinical trials, indicating strong capability in designing and executing detailed safety, tolerability, and efficacy studies for investigational agents and botanical substances.

Quick answers

Who was awarded contract 75F40121C00199?

75F40121C00199 was awarded to Altasciences Clinical Kansas Inc. by Food and Drug Administration (Department of Health and Human Services) on September 30, 2021.

How much is contract 75F40121C00199 worth?

The government has obligated $2,370,057 on 75F40121C00199.

Was contract 75F40121C00199 competed?

The extent of competition for 75F40121C00199 was full and open competition. The government received 1 offer.

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